Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Positive for Hepatitis B e Antigen

NCT01940471 | Completed Phase 3 Results DMC

• 2 other identifiers: GS-US-320-01102013-000636-10
• Study Type: interventional
• Target: 875
• Locations: 19 countries
• Sites: 160

Brief Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

Conditions

HBeAg-positive Chronic Hepatitis B

Keywords

Hepatitis; Tenofovir; Viread

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48

  Week 48

Secondary Outcomes (4)

• Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48

  Week 48

• Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

  Baseline, Week 48

• Percent Change From Baseline in Spine BMD at Week 48

  Baseline, Week 48

• Change From Baseline at Week 48 in Serum Creatinine

  Baseline, Week 48

Other Outcomes (1)

• Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48

  Up to 48 weeks

Study Arms (3)

TAF 25 mg

EXPERIMENTAL

TAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).

Drug: TAF; Drug: TDF Placebo

TDF 300 mg

ACTIVE COMPARATOR

TDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3).

Drug: TDF; Drug: TAF Placebo

Open-label TAF

EXPERIMENTAL

All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study. After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.

Drug: TAF

Interventions

TAF DRUG

25 mg tablet administered orally once daily

Also known as: Vemlidy®, GS-7340

Open-label TAF; TAF 25 mg

TDF DRUG

300 mg tablet administered orally once daily

Also known as: Viread®

TDF 300 mg

TAF Placebo DRUG

Tablet administered orally once daily

TDF 300 mg

TDF Placebo DRUG

Tablet administered orally once daily

TAF 25 mg

Eligibility Criteria

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

You may qualify if:

• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
• Adult males and non-pregnant, non-lactating females.
• Documented evidence of chronic HBV infection.
• HBeAg-positive, chronic hepatitis B with all of the following:
• HBeAg-positive at screening.
• Screening HBV DNA ≥ 2 x 10\^4 IU/mL
• Screening serum alanine aminotransferase (ALT) level \> 60 U/L (males) or \> 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN).
• Treatment-naive participants (defined as \< 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue) OR treatment-experienced participants (defined as participants meeting all entry criteria \[including HBV DNA and serum ALT criteria\] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue).
• Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit.
• Adequate renal function.
• Normal electrocardiogram (ECG).

You may not qualify if:

• Females who are breastfeeding.
• Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
• Co-infection with hepatitis C virus, human immunodeficiency virus (HIV), or hepatitis D virus.
• Evidence of hepatocellular carcinoma .
• Any history of, or current evidence of, clinical hepatic decompensation.
• Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) \> 10 x ULN.
• Received solid organ or bone marrow transplant.
• History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible.
• Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
• Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients.
• Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (160)

Coalition of Inclusive Medicine

Los Angeles, California, 90020, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Huntington Medical Research Institutes

Pasadena, California, 91105, United States

Location

Research and Education, Inc.

San Diego, California, 92105, United States

Location

Silicon Valley Research Institute

San Jose, California, 95128, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Digestive Disease Associates, PA

Catonsville, Maryland, 21228, United States

Location

Tufts Medical Center, Inc

Boston, Massachusetts, 02111, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Sing Chan Private Practice

Flushing, New York, 11354, United States

Location

New Discovery, LLC

Flushing, New York, 11355, United States

Location

Jefferson Medical College

Philadelphia, Pennsylvania, 19107, United States

Location

Xiaoli Ma, PC

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

Kelsey Research Foundation

Houston, Texas, 77005, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2137, Australia

Location

Westmead Hospital Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Tokuda Hospital - Sofia

Sofia, 1407, Bulgaria

Location

MHAT Alexandrovska Medical University, Sofia

Sofia, 1431, Bulgaria

Location

MMA Hospital of Active Treatment

Sofia, 1606, Bulgaria

Location

MHAT Sofia Med

Sofia, 1797, Bulgaria

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Zeidler Ledcor Centre Division of Gastroenterology / Department of Medicine

Edmonton, Alberta, T6G 2X8, Canada

Location

Liver and Intestinal Research Centre

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Dr. John Farley, Inc.

Vancouver, British Columbia, V6A 4B6, Canada

Location

Vancouver Infectious Disease Research and Care Centre

Vancouver, British Columbia, V6Z 2C7, Canada

Location

Gastrointestinal Research Institute (GIRI)

Vancouver, British Columbia, V6Z 2K5, Canada

Location

University of Manitoba, Health Sciences Center

Winnipeg, Manitoba, R3E 3P4, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network / Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Inspiration Research Limited

Toronto, Ontario, M5T 2S8, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Pitie Salpetriere

Paris, 75651, France

Location

Hopital Civil de Strasbourg

Strasbourg, 67091, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Lai Chi Kok, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Location

Tuen Mun Hospital

Tuenmen, Hong Kong

Location

BYL Nair Hospital & T N Medical College

Mumbai, Maharashtra, 400008, India

Location

Government Medical College and Superspecialty Hospital

Nagpur, Maharashtra, 440003, India

Location

Midas Multispecialty Hospital

Nagpur, Maharashtra, 440010, India

Location

SMS Medical College & Hospital

Jaipur, Rajasthan, 302004, India

Location

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

YR Gaitonde Centre for AIDS Research and Education

Chennai, 600113, India

Location

VGM Hospital

Coimbatore, 641005, India

Location

Gleneagles Global Hospital

Hyderabad, 500004, India

Location

Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals

Hyderabad, 500058, India

Location

S. R Kalla Memorial Gastro & General Hospital

Jaipur, 302001, India

Location

Peerless Hospital & B.K.Roy Research Center

Kolkata, 700 094, India

Location

Postgraduate Institute of Medical Education & Research

Kolkata, 700020, India

Location

Seth GS Medical College and KEM Hospital

Mumbai, 400012, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Institute of Liver and Biliary Sciences

New Delhi, 110070, India

Location

Global Hospital Super Specialty & Transplant Centre

Pārel, 400 012, India

Location

Nirmal Hospital

Surat, 395002, India

Location

Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Istituto Europeo di Oncologia

Bologna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di

Foggia, 71100, Italy

Location

Policlinico Universitario G. Martino via Consolare

Messina, 98124, Italy

Location

Azienda Ospedale San Paolo

Milan, 20142, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35100, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35121, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

Kyushu University Hospital

Fukuoka, Fukuoka-shi, 812-8582, Japan

Location

Shin-Kokura Hospital

Fukuoka, 803-8505, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

Kagawa Prefectural Central Hospital

Kagawa, 760-8557, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, 400-8506, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Japan Red Cross Musashino Hospital

Musashino, 180-8610, Japan

Location

Hyogo College of Medicine

Nishinomiya, 663-8501, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka Red Cross Hospital

Osaka, 543-8555, Japan

Location

Osaka University Hospital

Osaka, 545-8586, Japan

Location

National Hospital Organization Nagasaki Medical Center

Ōmura, 856-8562, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

Medical Hospital of Tokyo Medical and Dental University

Tokyo, 113-8519, Japan

Location

Auckland Clinical Studies Limited

Auckland, 1142, New Zealand

Location

Waikato Hospital (District Health Board)

Hamilton, 2001, New Zealand

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

Bialystok, 15-540, Poland

Location

Szpital Specjalistyczny

Chorzów, 41-500, Poland

Location

SPZOZ, Wojewódzki Specjalistyczny Szpital

Lodz, 91-347, Poland

Location

SP ZOZ Wojewódzki Szpital Zakazny

Warsaw, 01-201, Poland

Location

Centrum Badan Klinicznych

Wroclaw, 50-349, Poland

Location

Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

Bucharest, 021105, Romania

Location

Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"

Bucharest, 030303, Romania

Location

Spitatul Clinic de Boli Infectioase Constanta

Constanța, 900709, Romania

Location

Gastromedica SRL

Iași, 700506, Romania

Location

Spitalul Clinic Judetean de Urgenta Timisoara

Timișoara, 300736, Romania

Location

Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

Lipetsk, 398043, Russia

Location

Scientific Research Institute of Nutrition

Moscow, 115446, Russia

Location

People's Friendship University of Russia

Moscow, 117198, Russia

Location

1st Moscow State Medical University University Clinical Hospital #3

Moscow, 119435, Russia

Location

Limited Liability Company "Modern Medicine Clinic"

Moscow, 121170, Russia

Location

Institute of Clinical Immunology RAMS, Clinic of Immunopathology

Novosibirsk, 630084, Russia

Location

Scientific Research Institute of Clinical Immunology

Novosibirsk, 630099, Russia

Location

Municipal Clinical Hospital n.a. S.P. Botkin

Saint Petersburg, 191167, Russia

Location

Research Institute of Influenza

Saint Petersburg, 197376, Russia

Location

Medical Company Hepatology

Samara, 443063, Russia

Location

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, 620102, Russia

Location

National University Hospital Singapore

Singapore, 119228, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Changi General Hospital Pte Ltd.

Singapore, 529889, Singapore

Location

Kosin University College of Medicine

Busan, Seo-gu, 602702, South Korea

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

SoonChunHyang University Hospital Cheonan

Cheonan, 330-721, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Konyang University Hospital

Daejeon, 302-718, South Korea

Location

Inje University Ilsan Paik Hospital

Gyeonggi-do, 411-706, South Korea

Location

Ajou University Hospital

Gyeonggi-do, 443-380, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Seoul Saint Mary Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Chung-Ang University Hospital

Seoul, 156-755, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Yonsei Unversity Wonju

Wŏnju, 220-701, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 4103, Spain

Location

Chiayi Christian Hospital

Chiayi City, 60002, Taiwan

Location

Hualien Tzu Chi Medical Center

Hualien City, 970, Taiwan

Location

Kaohsiung Med. College Hosp. Dept. of Internal Medicine

Kaohsiung City, 80756, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Cathay General Hospital

Taipei, 10630, Taiwan

Location

Far-Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

Ankara, 06100, Turkey (Türkiye)

Location

University of Uludag

Bursa, 16059, Turkey (Türkiye)

Location

Dicle University Medical Faculty Department of Infectious Diseases

Diyarbakır, 21280, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpassa Tip Fakultesi Enfeksiyon

Istanbul, 34098, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100, Turkey (Türkiye)

Location

Barts & The London NHS Trust

London, E1 1BB, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (7)

• Buti M, Lim YS, Chan HLY, Agarwal K, Marcellin P, Brunetto MR, Chuang WL, Janssen HLA, Fung SK, Izumi N, Jablkowski MS, Abdurakhmanov D, Abramov F, Wang H, Botros I, Yee LJ, Mateo R, Flaherty JF, Osinusi A, Pan CQ, Shalimar X, Seto WK, Gane EJ. Eight-year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials. Aliment Pharmacol Ther. 2024 Dec;60(11-12):1573-1586. doi: 10.1111/apt.18278. Epub 2024 Sep 27.

  PMID: 39327857 DERIVED

• Lim YS, Chan HLY, Ahn SH, Seto WK, Ning Q, Agarwal K, Janssen HLA, Pan CQ, Chuang WL, Izumi N, Fung S, Shalimar, Brunetto M, Hui AJ, Chang TT, Lim SG, Abramov F, Flaherty JF, Wang H, Yee LJ, Kao JH, Gane E, Hou J, Buti M. Tenofovir alafenamide and tenofovir disoproxil fumarate reduce incidence of hepatocellular carcinoma in patients with chronic hepatitis B. JHEP Rep. 2023 Jul 13;5(10):100847. doi: 10.1016/j.jhepr.2023.100847. eCollection 2023 Oct.

  PMID: 37771546 DERIVED

• Chan HLY, Buti M, Lim YS, Agarwal K, Marcellin P, Brunetto M, Chuang WL, Janssen HLA, Fung S, Izumi N, Abdurakhmanov D, Jablkowski M, Celen MK, Ma X, Caruntu F, Flaherty JF, Abramov F, Wang H, Camus G, Osinusi A, Pan CQ, Shalimar, Seto WK, Gane E; GS-US-320-0110 and GS-US-320-0108 investigators. Long-Term Treatment With Tenofovir Alafenamide for Chronic Hepatitis B Results in High Rates of Viral Suppression and Favorable Renal and Bone Safety. Am J Gastroenterol. 2024 Mar 1;119(3):486-496. doi: 10.14309/ajg.0000000000002468. Epub 2023 Aug 9.

  PMID: 37561058 DERIVED

• Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, Shalimar, Buti M, Cox S, Parhy B, Zhou E, Martin R, Chang S, Lin L, Flaherty JF, Kitrinos KM, Gaggar A, Izumi N, Lim YS. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

  PMID: 30038044 DERIVED

• Seto WK, Asahina Y, Brown TT, Peng CY, Stanciu C, Abdurakhmanov D, Tabak F, Nguyen TT, Chuang WL, Inokuma T, Ikeda F, Santantonio TA, Habersetzer F, Ramji A, Lau AH, Suri V, Flaherty JF, Wang H, Gaggar A, Subramanian GM, Mukewar S, Brunetto MR, Fung S, Chan HL. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol. 2018 Jun 20:S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. Online ahead of print.

  PMID: 29933096 DERIVED

• Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Celen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.

  PMID: 29756595 DERIVED

• Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, Hui AJ, Janssen HL, Chowdhury A, Tsang TY, Mehta R, Gane E, Flaherty JF, Massetto B, Gaggar A, Kitrinos KM, Lin L, Subramanian GM, McHutchison JG, Lim YS, Acharya SK, Agarwal K; GS-US-320-0110 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):185-195. doi: 10.1016/S2468-1253(16)30024-3. Epub 2016 Sep 22.

  PMID: 28404091 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

Hepatitis

Interventions

tenofovir alafenamide; Tenofovir

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: September 12, 2013
• Study Start: September 11, 2013
• Primary Completion: November 16, 2015
• Study Completion: October 13, 2022
• Last Updated: October 10, 2023
• Results First Posted: March 30, 2017

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

RU (11); NZ (2); TW (8); GB (4); PL (5); RO (5); KR (22); BU (4); IN (18); FR (4); CA (12); ES (2); HK (5); JP (16); AU (11); IT (8); SG (3); TU (5); US (15)