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HBVPhase 3NCT02836236

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)

A Phase 3 study testing TAF and TDF in people with HBV and Chronic HBV Infection, run by Gilead Sciences at 29 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)-negative chronic hepatitis B virus (HBV) infection in China. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HBV, Chronic HBV Infection
What is being tested?
TAF and TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
29 sitesChina
Study dates
19 Jun 2015to 18 Sep 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following:
  • HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening
  • Screening HBV DNA ≥ 2 x 10^4 IU/mL
Show all 11Show fewer
  • 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 ECG

Who cannot join

  • 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, 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
Show all 13Show fewer
  • 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Ditan Hospital

    Beijing, 100015

  • No. 302 PLA Hospital

    Beijing, 100039

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Beijing Youan Hospital, Capital Medical University

    Beijing, 100069

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • XiangYa Hospital Central South University

    Changsha, 410008

  • The 2nd Xiangya Hospital Central South University

    Changsha, 410011

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

  • Guangzhou No.8 People's Hospital

    Guangzhou, 510060

  • Nanfang Medical University, Nanfang Hospital

    Guangzhou, 510515

  • The Affiliated Hospital of Guiyang Medical College

    Guiyang, Guiyang, 550004

  • The People's Hospital of Hainan Province

    Haikou, 570311

  • Jinan Infectious Disease Hospital

    Jinan, Shandong, 250021

  • No.1 Hospital Affiliated to Kunming Medical College

    Kunming, Yunnan, 650032

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing No. 2 Hospital

    Nanjing, Jiangsu

  • Jiangsu Provincial People's Hospital

    Nanjing, 210029

  • The 1st Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi Zhuang, 530021

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Shanghai Public Health Clinical Center

    Shanghai, 200083

  • 85 Hospital of People's Liberation Army

    Shanghai, 200235

  • The sixth People's Hospital of Shenyang

    Shenyang, Liaoning, 110006

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • The 3rd Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050051

  • Tongji Hospital, Tongji Medical college HuaZhong University of Science&Technology

    Wuhan, Hubei, 430030

  • First Affiliated Hospital of Xi'an Jiaotong

    Xi'an, 710061

Other trials in China

About this study

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

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)-negative chronic hepatitis B virus (HBV) infection in China.

Read the detailed description

This study GS-US-320-0108 is an international study planned to enroll participants in global countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study (NCT01940341) before China was able to participate. Therefore, this registration only includes the China cohorts as they were not part of the main study analysis. Data for China cohorts were analyzed separately after the main study analysis was completed.

Being tested
TAF, TDF, TAF Placebo, TDF Placebo
Keywords
Hepatitis, Tenofovir, Viread
Medical subject headings
Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAFDrug

    Also called GS-7340, Vemlidy®

    TAF 25 mg tablet administered orally once daily

  • TDFDrug

    Also called Viread®

    TDF 300 mg tablet administered orally once daily

  • TAF PlaceboDrug

    TAF placebo tablet administered orally once daily

  • TDF PlaceboDrug

    TDF placebo tablet administered orally once daily

Study groups in NCT02836236
Study groupRoleWhat they receive
Double-Blind TAFExperimentalTenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 144 weeks (per amendment 3.1).
Receives: Drug: TAF; Drug: TDF Placebo
Double-Blind TDFActive comparatorTDF 300 mg tablet + TAF placebo tablet once daily for up to 144 weeks (per amendment 3.1).
Receives: Drug: TDF; Drug: TAF Placebo
Open-label TAFExperimentalAll participants who complete the double-blind period will be eligible to receive open-label TAF until Week 384 of the study.
Receives: Drug: TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 48

Secondary outcomes (3)

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

    Measured: Baseline, Week 48

  2. Percent Change From Baseline in Spine BMD at Week 48

    Measured: Baseline, Week 48

  3. Change From Baseline in Serum Creatinine at Week 48

    Measured: Baseline, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2016 (estimated)
  2. Study start19 Jun 2015
  3. Primary completion5 Apr 2017
  4. Study completion18 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02836236
Sponsor's protocol ID
GS-US-320-0108 (China)
Other IDs
2013-000626-63
Status last verified
Sep 2024
First submitted
14 Jul 2016
Last updated
2 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

Publications

  • Hou J, Ning Q, Duan Z, Chen Y, Xie Q, Wang FS, Zhang L, Wu S, Tang H, Li J, Lin F, Yang Y, Gong G, Flaherty JF, Gaggar A, Mo S, Cheng C, Camus G, Chen C, Huang Y, Jia J, Zhang M; GS-US-320-0110 and GS-US-320-0108 China Investigators. 3-year Treatment of Tenofovir Alafenamide vs. Tenofovir Disoproxil Fumarate for Chronic HBV Infection in China. J Clin Transl Hepatol. 2021 Jun 28;9(3):324-334. doi: 10.14218/JCTH.2020.00145. Epub 2021 Apr 28.

    PubMed 34221918

  • Hou J, Ning Q, Duan Z, Chen Y, Xie Q, Zhang L, Wu S, Tang H, Li J, Lin F, Yang Y, Gong G, Luo Y, Xie S, Wang H, Mateo R, Yazdi T, Abramov F, Yee LJ, Flaherty J, Chen C, Huang Y, Zhang M, Jia J. Five-year Treatment with Tenofovir Alafenamide Achieves High Rates of Viral Suppression, Alanine Aminotransferase Normalization, and Favorable Bone and Renal Safety in Chinese Chronic Hepatitis B Patients. J Clin Transl Hepatol. 2024 May 28;12(5):469-480. doi: 10.14218/JCTH.2023.00417. Epub 2024 Apr 15.

    PubMed 38779514

  • 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.

    PubMed 37771546

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAF and TDF in people with HBV and Chronic HBV Infection, run by Gilead Sciences at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02836236, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.

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