A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT02219490 | Completed Phase 3 Results DMC

• 2 other identifiers: M14-4232014-001022-14
• Study Type: interventional
• Target: 1,596
• Locations: 26 countries
• Sites: 179

Brief Summary

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Conditions

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

Keywords

Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naive; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder

Outcome Measures

Primary Outcomes (6)

• All-Cause Death: Time to Event

  Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

  At Post-Treatment Weeks 52, 104, 156, 208, and 260

• Liver-Related Death: Time to Event

  Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

  At Post-Treatment Weeks 52, 104, 156, 208, and 260

• Liver Decompensation: Time to Event

  Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

  At Post-Treatment Weeks 52, 104, 156, 208, and 260

• Liver Transplantation: Time to Event

  Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

  At Post-Treatment Weeks 52, 104, 156, 208, and 260

• Hepatocellular Carcinoma: Time to Event

  Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

  At Post-Treatment Weeks 52, 104, 156, 208, and 260

• All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event

  Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.

  At Post-Treatment Weeks 52, 104, 156, 208, and 260

Secondary Outcomes (2)

• Change From Baseline in FibroScan Score by SVR12 Status

  At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260

• Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

  12 weeks after the last actual dose of study drug

Study Arms (1)

ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)

EXPERIMENTAL

Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.

Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)

Interventions

ABT-450/r/ABT-267 DRUG

Tablet for oral use

Also known as: ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, Paritaprevir/ritonavir/ombitasvir also known as Viekirax

ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)

ABT-333 DRUG

Tablet for oral use

Also known as: ABT-333 also known as dasabuvir, ABT-333 also known as Exviera

ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)

Ribavirin (RBV) DRUG

Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing \< 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.

ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 18 years old at screening
• Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
• Chronic hepatitis C, genotype 1 infection
• Males must be surgically sterile or agree to practice acceptable forms of birth control
• Screening laboratory result indicating HCV genotype 1 infection

You may not qualify if:

• Use of contraindicated medications within 2 weeks of dosing
• Abnormal laboratory tests
• Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
• Confirmed presence of hepatocellular carcinoma
• History of solid organ transplant

Sponsors & Collaborators

• AbbVie: lead

Study Sites (187)

CHU Bab El Oued /ID# 145420

Algiers, 16000, Algeria

Location

CHU Bologhine Hospital /ID# 145421

Algiers, 16000, Algeria

Location

CHU Mustapha Bacha /ID# 132130

Algiers, 16000, Algeria

Location

St Vincent's Hospital Sydney /ID# 131001

Darlinghurst, New South Wales, 2010, Australia

Location

Nepean Hospital /ID# 130999

Kingswood, New South Wales, 2747, Australia

Location

Westmead Hospital /ID# 130997

Westmead, New South Wales, 2145, Australia

Location

Greenslopes Private Hospital /ID# 131003

Greenslopes, Queensland, 4120, Australia

Location

Royal Brisbane and Women's Hospital /ID# 131004

Herston, Queensland, 4029, Australia

Location

Royal Adelaide Hospital /ID# 131002

Adelaide, South Australia, 5000, Australia

Location

St Vincent's Hospital Melbourne /ID# 131000

Fitzroy Melbourne, Victoria, 3065, Australia

Location

The Royal Melbourne Hospital /ID# 130998

Parkville, Victoria, 3050, Australia

Location

Medizinische Universitaet Graz /ID# 131018

Graz, Styria, 8036, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen /ID# 131017

Linz, Upper Austria, 4010, Austria

Location

Medizinische Universitaet Wien /ID# 131015

Vienna, Vienna, 1090, Austria

Location

Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020

Brussels, Brussels Capital, 1070, Belgium

Location

UCL Saint-Luc /ID# 131019

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 131021

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Tokuda Hospital Sofia /ID# 131022

Sofia, 1407, Bulgaria

Location

UMHAT Sveti Ivan Rilski /ID# 131026

Sofia, 1431, Bulgaria

Location

Univ Hosp for Active Treat /ID# 131023

Sofia, 1527, Bulgaria

Location

Diagnostic Consultative Center /ID# 131027

Sofia, 1612, Bulgaria

Location

UMHAT Sveta Marina /ID# 131025

Varna, 9010, Bulgaria

Location

University of Calgary /ID# 134370

Calgary, Alberta, T2N 4Z6, Canada

Location

GI Research & Associates /ID# 132169

Edmonton, Alberta, T5H 4B9, Canada

Location

LAIR Centre /ID# 130970

Vancouver, British Columbia, V5Z 1H3, Canada

Location

Vancouver Infectious Diseases Centre /ID# 134369

Vancouver, British Columbia, V6Z 2C7, Canada

Location

GIRI Gastrointestinal Research Institute /ID# 132171

Vancouver, British Columbia, V6Z 2K5, Canada

Location

University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Saint John Regional Hospital /ID# 131210

Saint John, New Brunswick, E2L 4L2, Canada

Location

Ottawa Hospital Research Institute /ID# 132170

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hospital /ID# 132134

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Liver Centre /ID# 132168

Toronto, Ontario, M6H 3M1, Canada

Location

Toronto Digestive Disease Asso /ID# 130968

Vaughan, Ontario, L4L 4Y7, Canada

Location

Clinique Medicale L'Actuel /ID# 132167

Montreal, Quebec, H2L 4P9, Canada

Location

Jewish General Hospital /ID# 132165

Montreal, Quebec, H3T 1E2, Canada

Location

Royal Victoria Hospital / McGill University Health Centre /ID# 132166

Montreal, Quebec, H4A 3J1, Canada

Location

CHU de Quebec-Université Laval hôpital CHUL /ID# 132132

Québec, Quebec, G1V 4G2, Canada

Location

Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031

Hvidovre, Capital Region, 2650, Denmark

Location

Odense University Hospital /ID# 131029

Odense C, Region Syddanmark, 5000, Denmark

Location

Aarhus Univ Hospital, Skejby /ID# 131030

Aarhus, 8200, Denmark

Location

Helsinki University Hospital /ID# 131034

Helsinki, Uusimaa, 00290, Finland

Location

Turku University Hospital /ID# 131032

Turku, 20520, Finland

Location

Hopital Saint Joseph /ID# 132177

Marseille, Bouches-du-Rhone, 13008, France

Location

CHU Limoges - Dupuytren 1 /ID# 131038

Limoges, Franche-Comte, 87042, France

Location

Hopital Haut-Lévêque /ID# 131036

Pessac, Gironde, 33604, France

Location

Hopital Saint Eloi /ID# 131037

Montpellier, Herault, 34295, France

Location

CHU de Nantes, Hotel Dieu -HME /ID# 132179

Nantes, Pays de la Loire Region, 44000, France

Location

Hopital Jean Verdier /ID# 135877

Bondy, 93140, France

Location

CHU Grenoble - Hopital Michallon /ID# 131041

La Tronche, 38700, France

Location

HCL - Hopital de la Croix-Rousse /ID# 131042

Lyon, 69004, France

Location

Duplicate_Hopital lArchet 2 /ID# 131040

Nice, 06202, France

Location

CHRU Pontchaillou /ID# 132173

Rennes, 35033, France

Location

CHU Strasbourg - Hopital Civil /ID# 132174

Strasbourg, 67091, France

Location

Hopital Universitaire Purpan Hopital Rangueil /ID# 131035

Toulouse, 31059, France

Location

Universitaetsklinikum Freiburg /ID# 131044

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitaetsklinik Heidelberg /ID# 134371

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

LMU Klinikum der Universitat Muchen /ID# 131049

Munich, Bavaria, 81377, Germany

Location

Universitaetsklinikum Frankfurt /ID# 131055

Frankfurt am Main, Hesse, 60590, Germany

Location

Zentru fur HIV und Heaptogastroenterologie /ID# 131052

Düsseldorf, North Rhine-Westphalia, 40237, Germany

Location

Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050

Herne, North Rhine-Westphalia, 44623, Germany

Location

Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053

Berlin, 13353, Germany

Location

Universitaetsklinikum Essen /ID# 131048

Essen, 45147, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover /ID# 131054

Hanover, 30625, Germany

Location

Centrum für interdisziplinaere Medizin /ID# 131046

Münster, 48143, Germany

Location

General Hospital of Athens Ippokratio /ID# 131057

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Laiko /ID# 131088

Athens, Attica, 11527, Greece

Location

General University Hospital of Alexandroupolis /ID# 131056

Alexandroupoli, 68100, Greece

Location

Beaumont Hospital /ID# 131089

Beaumont, Dublin, D09 XR63, Ireland

Location

St James Hospital /ID# 132180

Dublin, Dublin, D08 NHY1, Ireland

Location

St Vincent's University Hospital /ID# 132181

Elm Park, Dublin, D04 T6F4, Ireland

Location

The Chaim Sheba Medical Center /ID# 131092

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 132182

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rambam Health Care Campus /ID# 131090

Haifa, 3109601, Israel

Location

The Lady Davis Carmel Medical Center /ID# 131091

Haifa, 34362, Israel

Location

Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095

Bologna, Emilia-Romagna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102

Cona, Ferrara, 44124, Italy

Location

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Policlinico Agostino Gemelli /ID# 131098

Rome, Lazio, 00168, Italy

Location

Ospedale San Raffaele IRCCS /ID# 131093

Milan, Lombardy, 20132, Italy

Location

Fondazione PTV Policlinico Tor Vergata /ID# 132185

Rome, Roma, 00133, Italy

Location

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188

Bergamo, 24127, Italy

Location

Azienda Ospedaliero Universitaria Careggi /ID# 132197

Florence, 50134, Italy

Location

Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195

Foggia, 71122, Italy

Location

A.O.U. Policlinico G. Martino /ID# 132193

Messina, 98125, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097

Milan, 20122, Italy

Location

Ospedale S Giuseppe /ID# 132194

Milan, 20123, Italy

Location

ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198

Milan, 20142, Italy

Location

ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372

Milan, 20157, Italy

Location

Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104

Milan, 20162, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 131096

Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 132191

Napoli, 80131, Italy

Location

Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184

Palermo, 90127, Italy

Location

Azienda Ospedaliero-Universitaria di Parma /ID# 132183

Parma, 43126, Italy

Location

Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192

Salerno, 84131, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100

Turin, 10126, Italy

Location

Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196

Udine, 33100, Italy

Location

Hospital General de Tijuana /ID# 130972

Tijuana, Estado de Baja California, 22680, Mexico

Location

Cife /Id# 130974

Guadalajara, Jalisco, 44160, Mexico

Location

Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975

Distrito Federal, 14000, Mexico

Location

CIF-BIOTEC/Medica Sur /ID# 134971

Mexico City, 14050, Mexico

Location

ITESM campus Ciudad de Mexico /ID# 132383

Mexico City, 14380, Mexico

Location

Instituto Metropolitano de Inv /ID# 132201

Tlalpan, 14308, Mexico

Location

Erasmus Medisch Centrum /ID# 132206

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Academisch Medisch Centrum /ID# 132205

Amsterdam, 1105 AZ, Netherlands

Location

Leids Universitair Medisch Centrum /ID# 132204

Leiden, 2333 ZA, Netherlands

Location

Akershus Universitetssykehus_MAIN /ID# 132212

Lorenskog, Akershus, 1478, Norway

Location

St. Olavs Hospital HF /ID# 132213

Trondheim, Sor-Trondelag, 7006, Norway

Location

Stavanger University Hospital /ID# 132211

Stavanger, 4068, Norway

Location

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115

Lublin, Lublin Voivodeship, 20-081, Poland

Location

Wojewodzki Szpital Zakazny /ID# 131112

Warsaw, Masovian Voivodeship, 01-201, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

ID Clinic /ID# 131111

Mysłowice, Silesian Voivodeship, 41-406, Poland

Location

Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107

Lodz, Łódź Voivodeship, 91-347, Poland

Location

Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116

Lisbon, 1169-050, Portugal

Location

Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117

Porto, 4099-001, Portugal

Location

Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120

Sector 2, București, 021105, Romania

Location

Institutul Clinic Fundeni /ID# 131121

Sector 2, București, 022328, Romania

Location

Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126

Timișoara, Timiș County, 300310, Romania

Location

Institutul Nat. de Boli Infectioase /ID# 131124

Bucharest, 010825, Romania

Location

SC Gastromedica SRL /ID# 131127

Iași, 700506, Romania

Location

Medical Company Hepatolog /ID# 132277

Samara, Samara Oblast, 443063, Russia

Location

Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270

Kazan', Tatarstan, Respublika, 420140, Russia

Location

South-Ural State Med. Academy /ID# 132274

Chelyabinsk, 454052, Russia

Location

Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269

Kemerovo, 650056, Russia

Location

Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278

Krasnoyarsk, 660049, Russia

Location

Moscow Clinical Scientific Center n.a. Loginov /ID# 132266

Moscow, 111123, Russia

Location

Central Clinical Hospital of Russian Academy of Science /ID# 132289

Moscow, 117593, Russia

Location

I. M. Sechenov First Moscow State Medical University /ID# 132275

Moscow, 119991, Russia

Location

City Clinical Hospital #24 /ID# 132268

Moscow, 127015, Russia

Location

Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288

Moscow, 129090, Russia

Location

Clinical Infectious Diseases Hospital #1 /ID# 132272

Novosibirsk, 630099, Russia

Location

Samara State Medical University /ID# 136913

Samara, 443099, Russia

Location

Stavropol State Medical University /ID# 132279

Stavropol, 355017, Russia

Location

Tolyatti City Clinical Hospital #1 /ID# 132273

Tolyatti, 445009, Russia

Location

Multidisciplinary Consultative and Diagnostic Center /ID# 131130

Tyumen, 625026, Russia

Location

Sverdlovsk Regional Clinical Hospital #1 /ID# 132267

Yekaterinburg, 620102, Russia

Location

King Abdulaziz Medical City /ID# 145129

Jeddah, 21423, Saudi Arabia

Location

Ministry Nat Guard Hosp Health /ID# 145126

Riyadh, 11426, Saudi Arabia

Location

King Khalid University Hospita /ID# 132291

Riyadh, 11472, Saudi Arabia

Location

Hospital Universitari Son Espases /ID# 131140

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario Germans Trias i Pujol /ID# 132293

Badalona, Barcelona, 08916, Spain

Location

Hospital Unversitario Marques de Valdecilla /ID# 131141

Santander, Cantabria, 39008, Spain

Location

Hospital Donostia /ID# 131144

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Hospital General Universitario Santa Lucia /ID# 131139

Cartagena, Murcia, 30202, Spain

Location

Hospital Universitario Central de Asturias /ID# 131138

Oviedo, Principality of Asturias, 33011, Spain

Location

OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario A Coruna - CHUAC /ID# 131137

A Coruña, 15006, Spain

Location

Hospital Universitario Reina Sofia /ID# 131135

Córdoba, 14004, Spain

Location

Hospital Universitario de la Princesa /ID# 131131

Madrid, 28006, Spain

Location

Hospital Universitario 12 de Octubre /ID# 131133

Madrid, 28041, Spain

Location

Hospital Universitario La Paz /ID# 131132

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 131136

Málaga, 29010, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 131134

Seville, 41013, Spain

Location

Hospital Clinico Universitario Lozano Blesa /ID# 132292

Zaragoza, 50009, Spain

Location

Skane University hospital /ID# 131146

Malmo, Skåne County, 214 28, Sweden

Location

Karolinska University Hospital Solna /ID# 131145

Solna, Stockholm County, 171 64, Sweden

Location

Sahlgrenska University Hospital /ID# 131147

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Kantonsspital St. Gallen /ID# 131148

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Universitätsspital Zürich /ID# 134881

Zurich, Canton of Zurich, 8091, Switzerland

Location

Inselspital, Universitätsspital Bern /ID# 132294

Bern, 3010, Switzerland

Location

Izmir Tepecik Training and Research Hospital /ID# 134968

Konak, İzmir, 35180, Turkey (Türkiye)

Location

Hacettepe University Faculty of Medicine /ID# 131150

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Univ Medical Faculty /ID# 131151

Ankara, 06590, Turkey (Türkiye)

Location

Uludag University Medical Faculty /ID# 132297

Bursa, 16059, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty /ID# 131153

Istanbul, 34093, Turkey (Türkiye)

Location

Ege University Medical Faculty /ID# 132298

Izmir, 35040, Turkey (Türkiye)

Location

Karadeniz University /ID# 131152

Trabzon, 61000, Turkey (Türkiye)

Location

Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306

Poole, Dorset, BH15 2JB, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust /ID# 131161

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Barts Health NHS Trust /ID# 132302

London, London, City of, E1 2ES, United Kingdom

Location

The Royal Free London NHS Foundation Trust /ID# 131159

London, London, City of, NW3 2QG, United Kingdom

Location

Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

NHS Greater Glasgow and Clyde /ID# 131162

Glasgow, Scotland, G12 0XH, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 131154

Birmingham, B15 2TH, United Kingdom

Location

Duplicate_NHS Tayside /ID# 132300

Dundee, DD2 1UB, United Kingdom

Location

NHS Lothian /ID# 134368

Edinburgh, EH3 9HE, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust /ID# 132305

Leeds, LS9 7TF, United Kingdom

Location

King's College Hospital NHS Foundation Trusts /ID# 131157

London, SE5 9RS, United Kingdom

Location

University Hospital Plymouth NHS Trust /ID# 131160

Plymouth, PL6 5FP, United Kingdom

Location

Portsmouth Hospitals University NHS Trust /ID# 131158

Portsmouth, PO6 3LY, United Kingdom

Location

Northern Care Alliance NHS Group /ID# 131156

Salford, M6 8HD, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust /ID# 132301

Tooting, SW17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Fibrosis

Interventions

paritaprevir; ombitasvir; dasabuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 19, 2014
• Study Start: October 30, 2014
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

DK (3); BU (5); DE (12); IE (3); AU (3); NL (3); GR (3); ES (15); FR (12); NO (3); PL (6); SE (3); CH (3); RU (16); RO (5); AL (3); IL (4); PT (4); TU (7); CA (15); SA (3); ME (6); GB (15); IT (22); BE (3); FI (2)