Chronic Hepatitis BPhase 2NCT02174276
Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
A Phase 2 study testing Tenofovir disoproxil fumarate and GS-4774 in people with Chronic Hepatitis B, run by Gilead Sciences at 33 sites in 6 countries.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Tenofovir disoproxil fumarate and GS-4774
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 33 sitesin 6 countries
- Study dates
- 24 Jul 2014to 30 May 2018
- Phase
- Phase 2
- 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
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
- Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
- Screening HBV DNA ≥ 2000 IU/mL
- A negative serum pregnancy test is required for females (unless surgically sterile or > 2 years post-menopausal)
Who cannot join
- Cirrhosis
- Inadequate liver function
- Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
- Received antiviral treatment for HBV within 3 months of screening
- Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
- Significant cardiovascular, pulmonary, or neurological disease
Show all 17Show fewer
- Women who are pregnant or may wish to become pregnant during the course of the study
- Received solid organ or bone marrow transplant
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
- Use of investigational agents within 3 months of screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Documented history of yeast allergy
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
United States12 sites
Digestive Disease Associates, PA
Baltimore, Maryland
Tufts Medical Center
Boston, Massachusetts
The Queen's Medical Center
Honolulu, Hawaii
Icahn School of Medicine at Mount Sinai
New York, New York
Stanford University Medical Center
Palo Alto, California
Xiaoli Ma, PC
Philadelphia, Pennsylvania
Virginia Commonwealth University
Richmond, Virginia
Kaiser Permanente
Sacramento, California
Research and Education, Inc.
San Diego, California
Kaiser Permanente San Francisco
San Francisco, California
Silicon Valley Research Institute
San Jose, California
Kaiser Permanente
Springfield, Virginia
South Korea8 sites
Kyungpook National University Hospital
Daegu
The Catholic University of Korea
Seocho
Seoul National University Bundang Hospital
Seongnam
Samsung Medical Center
Seoul
Seoul National University College of Medicine
Seoul
Yonsei Universiity
Seoul
Pusan National University Yangsan Hospital
Yangsan
The Catholic University of Korea
Yangsan
Canada6 sites
Toronto General Hospital-The University Health Network
Toronto, Ontario
Toronto Liver Centre
Toronto, Ontario
Toronto Western Hospital-The University Health Network
Toronto, Ontario
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia
Liver and Intestinal Research Center
Vancouver, British Columbia
University of Manitoba
Winnipeg, Manitoba
Italy4 sites
Aou-S.Orsola-Malpighi - Universita Degli Studi Di
Bologna
Azienda Ospedaliero-Universitaria di Parma
Parma
Azienda Ospedaliero-Universitaria Pisana
Pisa
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo
Romania2 sites
Dr. Victor Babes Hospital for Infectious Diseases
Bucharest
Institutul National de Boli Infectioase Prof.Dr. Matei Bals
Bucharest
About this study
Official title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- Tenofovir disoproxil fumarate, GS-4774
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarateDrug
Also called TDF, Viread®
TDF 300 mg tablet administered orally once daily
GS-4774Biological
GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses
| Study group | Role | What they receive |
|---|---|---|
| TDF 48 weeks | Active comparator | Participants will receive TDF for 48 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. Receives: Drug: Tenofovir disoproxil fumarate |
| TDF plus GS-4774 2 YU | Experimental | Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. Receives: Drug: Tenofovir disoproxil fumarate; Biological: GS-4774 |
| TDF plus GS-4774 10 YU | Experimental | Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. Receives: Drug: Tenofovir disoproxil fumarate; Biological: GS-4774 |
| TDF plus GS-4774 40 YU | Experimental | Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. Receives: Drug: Tenofovir disoproxil fumarate; Biological: GS-4774 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Serum HBsAg From Baseline to Week 24
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).
Measured: Baseline to Week 24
Secondary outcomes (18)
Mean Change in HBsAg From Baseline to Week 12
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Measured: Baseline to Week 12
Mean Change in HBsAg From Baseline to Week 48
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.
Measured: Baseline to Week 48
Percentage of Participants With HBsAg Loss at Week 24
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 24
Percentage of Participants With HBsAg Loss at Week 48
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 48
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Measured: Baseline to Week 24
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.
Measured: Baseline to Week 48
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 12
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 24
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 48
Percentage of Participants With HBeAg Loss at Week 24
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 24
Percentage of Participants With HBeAg Loss at Week 48
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.
Measured: Baseline to Week 48
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Measured: Baseline to Week 24
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.
Measured: Baseline to Week 48
Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
The LLOQ was defined as 20 IU/mL.
Measured: Week 24
Percentage of Participants With HBV DNA < LLOQ at Week 48
The LLOQ was defined as 20 IU/mL.
Measured: Week 48
Percentage of Participants Experiencing Virologic Breakthrough at Week 24
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Measured: Baseline to Week 24
Percentage of Participants Experiencing Virologic Breakthrough at Week 48
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.
Measured: Baseline to Week 48
Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing.
Measured: Baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study start24 Jul 2014
- Primary completion17 Feb 2016
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174276
- Sponsor's protocol ID
- GS-US-330-1401
- Other IDs
- 2014-001011-39, 2014
- Status last verified
- May 2019
- First submitted
- 23 Jun 2014
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Janssen HL, Yoon SK, Yoshida EM, Trinh HN, Rodell TC, Nguyen AH, et al. Safety and Efficacy of GS-4774 in combination with TDF in Patients with Chronic Hepatitis B not on Antiviral Medication [Abstract 231]. Hepatology AASLD Abstracts 2016;64 (Suppl S1):122A.
Boni C, Janssen HLA, Rossi M, Yoon SK, Vecchi A, Barili V, Yoshida EM, Trinh H, Rodell TC, Laccabue D, Alfieri A, Brillo F, Fisicaro P, Acerbi G, Pedrazzi G, Andreone P, Cursaro C, Margotti M, Santoro R, Piazzolla V, Brunetto MR, Coco B, Cavallone D, Zhao Y, Joshi A, Woo J, Lau AH, Gaggar A, Subramanian GM, Massetto B, Fung S, Ahn SH, Ma X, Mangia A, Ferrari C. Combined GS-4774 and Tenofovir Therapy Can Improve HBV-Specific T-Cell Responses in Patients With Chronic Hepatitis. Gastroenterology. 2019 Jul;157(1):227-241.e7. doi: 10.1053/j.gastro.2019.03.044. Epub 2019 Mar 28.
PubMed 30930022
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment
- ClinicalTrials.gov ID
- NCT02174276
- Acronym / sponsor ID
- GS-US-330-1401
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 17 Feb 2016 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TDF 48 weeks | Active comparator | Drug: Tenofovir disoproxil fumarateParticipants will receive TDF for 48 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. |
| TDF plus GS-4774 2 YU | Experimental | Drug: Tenofovir disoproxil fumarate, Biological: GS-4774Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. |
| TDF plus GS-4774 10 YU | Experimental | Drug: Tenofovir disoproxil fumarate, Biological: GS-4774Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. |
| TDF plus GS-4774 40 YU | Experimental | Drug: Tenofovir disoproxil fumarate, Biological: GS-4774Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
- Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
- Screening HBV DNA ≥ 2000 IU/mL
- A negative serum pregnancy test is required for females (unless surgically sterile or > 2 years post-menopausal)
Key exclusion criteria (17 listed)
- Cirrhosis
- Inadequate liver function
- Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
- Received antiviral treatment for HBV within 3 months of screening
- Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxil fumarateAlso: TDF, Viread®TDF 300 mg tablet administered orally once daily | Drug | TDF 48 weeks, TDF plus GS-4774 10 YU, TDF plus GS-4774 2 YU, TDF plus GS-4774 40 YU |
| GS-4774GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses | Biological | TDF plus GS-4774 10 YU, TDF plus GS-4774 2 YU, TDF plus GS-4774 40 YU |
Primary outcome
Mean Change in Serum HBsAg From Baseline to Week 24
Time frame: Baseline to Week 24
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).
18 secondary outcomes
Mean Change in HBsAg From Baseline to Week 12
Time frame: Baseline to Week 12
Mean Change in HBsAg From Baseline to Week 48
Time frame: Baseline to Week 48
Percentage of Participants With HBsAg Loss at Week 24
Time frame: Baseline to Week 24
Percentage of Participants With HBsAg Loss at Week 48
Time frame: Baseline to Week 48
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
Time frame: Baseline to Week 24
Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
Time frame: Baseline to Week 48
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
Time frame: Baseline to Week 12
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
Time frame: Baseline to Week 24
Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
Time frame: Baseline to Week 48
Percentage of Participants With HBeAg Loss at Week 24
Time frame: Baseline to Week 24
Percentage of Participants With HBeAg Loss at Week 48
Time frame: Baseline to Week 48
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
Time frame: Baseline to Week 24
Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
Time frame: Baseline to Week 48
Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
Time frame: Week 24
Percentage of Participants With HBV DNA < LLOQ at Week 48
Time frame: Week 48
Percentage of Participants Experiencing Virologic Breakthrough at Week 24
Time frame: Baseline to Week 24
Percentage of Participants Experiencing Virologic Breakthrough at Week 48
Time frame: Baseline to Week 48
Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
Time frame: Baseline to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationJanssen HL, Yoon SK, Yoshida EM, Trinh HN, Rodell TC, Nguyen AH, et al. Safety and Efficacy of GS-4774 in combination with TDF in Patients with Chronic Hepatitis B not on Antiviral Medication [Abstract 231]. Hepatology AASLD Abstracts 2016;64 (Suppl S1):122A.
- Results publication: PubMed 30930022Boni C, Janssen HLA, Rossi M, Yoon SK, Vecchi A, Barili V, Yoshida EM, Trinh H, Rodell TC, Laccabue D, Alfieri A, Brillo F, Fisicaro P, Acerbi G, Pedrazzi G, Andreone P, Cursaro C, Margotti M, Santoro R, Piazzolla V, Brunetto MR, Coco B, Cavallone D, Zhao Y, Joshi A, Woo J, Lau AH, Gaggar A, Subramanian GM, Massetto B, Fung S, Ahn SH, Ma X, Mangia A, Ferrari C. Combined GS-4774 and Tenofovir Therapy Can Improve HBV-Specific T-Cell Responses in Patients With Chronic Hepatitis. Gastroenterology. 2019 Jul;157(1):227-241.e7. doi: 10.1053/j.gastro.2019.03.044. Epub 2019 Mar 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenofovir disoproxil fumarate and GS-4774 in people with Chronic Hepatitis B, run by Gilead Sciences at 33 sites in 6 countries.
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 4 inclusion and 17 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, South Korea, Canada, Italy, Romania and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Jun 2019). 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?
Mean Change in Serum HBsAg From Baseline to Week 24 (time frame: Baseline to Week 24). 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 NCT02174276, which also lists 2 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 4 Jun 2019.