A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

NCT01482390 | Completed Phase 2 FDA Drug

• 2 other identifiers: NV277792011-002715-28
• Study Type: interventional
• Target: 80
• Locations: 7 countries
• Sites: 39

Brief Summary

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test

  12 weeks after end of treatment (up to Week 60)

Secondary Outcomes (9)

• Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test

  4 weeks after end of treatment (up to Week 52)

• Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test

  24 weeks after end of treatment (up to Week 72)

• Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test

  Weeks 2, 4, 12, 24, and 48

• Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology

  Baseline up to Week 60

• Change From Baseline in HCV Ribonucleic Acid (RNA) Levels

  Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72

Study Arms (4)

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)

EXPERIMENTAL

Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks).

Drug: Ribavirin; Drug: Mericitabine; Drug: Peginterferon Alfa-2a; Drug: Telaprevir

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)

EXPERIMENTAL

Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

Drug: Ribavirin; Drug: Mericitabine; Drug: Peginterferon Alfa-2a; Drug: Telaprevir

TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

EXPERIMENTAL

Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

Drug: Ribavirin; Drug: Mericitabine; Drug: Peginterferon Alfa-2a; Drug: Placebo; Drug: Telaprevir

TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)

ACTIVE COMPARATOR

Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

Drug: Ribavirin; Drug: Peginterferon Alfa-2a; Drug: Placebo; Drug: Telaprevir

Interventions

Ribavirin DRUG

Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.

Also known as: Copegus

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks); TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks); TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks); TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

Mericitabine DRUG

Participants will receive mericitabine 1000 mg orally twice daily.

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks); TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks); TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

Peginterferon Alfa-2a DRUG

Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.

Also known as: Pegasys

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks); TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks); TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks); TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

Placebo DRUG

Participants will receive placebo matching to mericitabine orally twice daily.

TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks); TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

Telaprevir DRUG

Participants will receive telaprevir 750 mg orally three times daily.

TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks); TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks); TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks); TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

Eligibility Criteria

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

You may qualify if:

• Chronic hepatitis C infection for at least 6 months duration
• Hepatitis C genotype 1a or 1b
• Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
• Participants showed a previous null response to therapy as defined by \< 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

You may not qualify if:

• Hepatitis C infection with a genotype other than genotype 1a or 1b
• Body mass index \< 18 or \>= 36 kilograms per square meters (kg/m\^2)
• Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
• Herbal remedies \<=1 month prior to the first dose of study drug

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (39)

Birmingham Gastro Associates, P.C.

Birmingham, Alabama, 35209, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

Location

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Gastroenterology Group of Naples

Naples, Florida, 34102, United States

Location

John Hopkins Hospital

Lutherville, Maryland, 21093, United States

Location

Metrowest Medical Center

Framingham, Massachusetts, 01702, United States

Location

Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

St Louis, Missouri, 63104, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Carolina'S Center For Liver Disease

Statesville, North Carolina, 28677, United States

Location

Uni of Cincinnati College of Medicine; Div. of Digestive Diseases

Cincinnati, Ohio, 45267-0595, United States

Location

Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons

Dallas, Texas, 75246, United States

Location

McGuire; Veteran Affairs Med Ctr

Richmond, Virginia, 23249, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GI Research Institute; Gastroenterology & Hepatology

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Percuro Clinical Research Ltd.

Victoria, British Columbia, V8V 3P9, Canada

Location

Winnipeg Regional Health Authority; Section of Hepatology

Winnipeg, Manitoba, R3A 1R9, Canada

Location

University Health Network - Toronto Western Hospital; Hepatology

Toronto, Ontario, M5G 1L7, Canada

Location

Toronto Digest. Disease Asso.

Woodbridge, Ontario, L4L 4Y7, Canada

Location

McGill University, Montreal Chest Institute; Viral and other Infectious

Montreal, Quebec, H2X2P4, Canada

Location

Hopital Claude Huriez;Gastro Enterologie

Lille, 59037, France

Location

Fondation Hopital Saint Joseph; Gastro-Enterologie

Marseille, 13285, France

Location

Hopital Purpan;Gastro Enterologie Hepatologie

Toulouse, 31059, France

Location

Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

Frankfurt am Main, 60590, Germany

Location

Uniklinik Freiburg; Abteilung Innere Medizin II

Freiburg im Breisgau, 79106, Germany

Location

Universitäts Klinikum; Schleswig-Holstein Kiel

Kiel, 24105, Germany

Location

UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

Bologna, Emilia-Romagna, 40138, Italy

Location

ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive

Milan, Lombardy, 20162, Italy

Location

Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

Pisa, Tuscany, 56124, Italy

Location

Hospital Universitario de Canarias; Servicio de Digestivo

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

Barcelona, 08035, Spain

Location

Hospital Clinic I Provincial; Servicio de Digestivo

Barcelona, 08036, Spain

Location

Hospital Carlos III; Laboratorio de Biologia Molecular

Madrid, 28029, Spain

Location

Royal Bournemouth Hospital, Gastroenterology

Dorset, BH7 7DW, United Kingdom

Location

King'S College Hospital; Institute of Liver Studies

London, SE5 9RS, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.

  PMID: 26752189 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin; 2'-fluoro-2'-methyl-3',5'-diisobutyryldeoxycytidine; peginterferon alfa-2a; telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: November 30, 2011
• Study Start: November 30, 2011
• Primary Completion: January 31, 2014
• Study Completion: January 31, 2014
• Last Updated: April 24, 2017

Record last verified: 2017-04

Locations

ES (4); GB (4); US (15); IT (3); FR (3); DE (3); CA (7)