Chronic Hepatitis BPhase 2NCT02579382
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
A Phase 2 study testing TDF and Vesatolimod in people with Chronic Hepatitis B, run by Gilead Sciences at 21 sites in 8 countries.
Trial summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TDF and Vesatolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 10 Nov 2015to 3 May 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females between the ages of 18-65
- Chronic hepatitis B virus (HBV) infection
- HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening
Who cannot join
- Extensive bridging fibrosis or cirrhosis
- Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)
- Chronic liver disease other than HBV
- Lactating or pregnant females or those that wish to become pregnant during the course of the study
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
21 sites in 8 countries.
21 sites in 8 countries
United States9 sites
Study site
Boston, Massachusetts
Study site
Catonsville, Maryland
Study site
Flushing, New York
Study site
Honolulu, Hawaii
Study site
Los Angeles, California
Study site
Palo Alto, California
Study site
Philadelphia, Pennsylvania
Study site
San Diego, California
Study site
San Francisco, California
Italy4 sites
Study site
Bologna
Study site
Milan
Study site
Pisa
Study site
San Giovanni Rotondo
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 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 vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.
- Conditions
- Chronic Hepatitis B
- Being tested
- TDF, Vesatolimod, Placebo
- Keywords
- HBV, Hepatitis, Liver Disease
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDFDrug
Also called Viread®
300 mg tablets administered orally once daily
VesatolimodDrug
Also called GS-9620
Tablets administered orally once a week (every 7 days) for 12 doses
PlaceboDrug
Placebo administered orally once a week (every 7 days) for 12 doses
| Study group | Role | What they receive |
|---|---|---|
| TDF + placebo | Placebo comparator | Main Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. Receives: Drug: TDF; Drug: Placebo |
| TDF + Vesatolimod 1 mg | Experimental | Main Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. Receives: Drug: TDF; Drug: Vesatolimod |
| TDF + Vesatolimod 2 mg | Experimental | Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. Receives: Drug: TDF; Drug: Vesatolimod |
| TDF + Vesatolimod 4 mg | Experimental | Main Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses.
Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. Receives: Drug: TDF; Drug: Vesatolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (> 19 vs ≤ 19 IU/L for females; > 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
Measured: Baseline; Week 24
Secondary outcomes (22)
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative Hepatitis B Envelope Antibody (HBeAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Measured: Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAg seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Measured: Week 48
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative Hepatitis B Surface Antibody (HBsAb) result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Measured: Week 24
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg result changing from positive at baseline to negative at any postbaseline visit. HBsAg seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. The Missing (M) = Failure (F) approach was used for this analysis.
Measured: Week 48
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
Measured: Baseline; Week 12
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
Measured: Baseline; Week 48
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Measured: Baseline to Week 12
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 24 post-baseline visit.
Measured: Baseline to Week 24
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
HBsAg ≥ 0.5 log10 IU/mL decline was defined as a decline from baseline in log10 IU/mL serum HBsAg ≥ 0.5 at the Week 12 post-baseline visit. Missing values were considered failures.
Measured: Baseline to Week 48
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (LLOQ) at Week 24
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Measured: Week 24
Percentage of Participants With HBV DNA < LLOQ at Week 48
LLOQ for HBV DNA was defined as 20 IU/mL. The participants with missing information were excluded from the analysis.
Measured: Week 48
Percentage of Participants Experiencing Virologic Breakthrough
Virologic breakthrough was defined as confirmed HBV DNA ≥ 69 IU/mL after having had HBV DNA < 69 IU/mL or confirmed 1.0 log10 IU/mL or greater increase in HBV DNA from nadir. Confirmation requires 2 consecutive occurrences of elevation in HBV DNA to > 69 IU/mL after having had HBV DNA < 69 IU/mL or 1.0 log10 IU/mL or greater increases in HBV DNA from nadir.
Measured: Weeks 24 and 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
Sequence analysis of the HBV pol/RT was attempted for any participant who had HBV DNA ≥ 69 IU/mL at Week 48 or early discontinuation. Results of the alignment of Week 48 and baseline sequence were reported as a change from baseline sequence.
Measured: Baseline; Week 48
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: AUCinf of Vesatolimod
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: %AUCexp of Vesatolimod
%AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Cmax of Vesatolimod
Cmax is defined as the maximum concentration of drug.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Clast of Vesatolimod
Clast is defined as the last observable concentration of drug.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tmax of Vesatolimod
Tmax is defined as the time (observed time point) of Cmax
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tlast of Vesatolimod
Tlast is defined as the time (observed time point) of Clast.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: T1/2 of Vesatolimod
T1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: CL/F of Vesatolimod
CL/F is defined as the apparent oral clearance following administration of the drug.
Measured: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start10 Nov 2015
- Primary completion16 Jan 2017
- Study completion3 May 2019
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 (3)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 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
- NCT02579382
- Sponsor's protocol ID
- GS-US-283-1062
- Other IDs
- 2015-002017-30, 2015
- Status last verified
- May 2020
- First submitted
- 15 Oct 2015
- Last updated
- 18 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agarwal K, Ahn SH, Elkhashab M, Lau AH, Gaggar A, Bulusu A, Tian X, Cathcart AL, Woo J, Subramanian GM, Andreone P, Kim HJ, Chuang WL, Nguyen MH. Safety and efficacy of vesatolimod (GS-9620) in patients with chronic hepatitis B who are not currently on antiviral treatment. J Viral Hepat. 2018 Nov;25(11):1331-1340. doi: 10.1111/jvh.12942. Epub 2018 Aug 22.
PubMed 29851204Younossi ZM, Stepanova M, Janssen H, Agarwal K, Nguyen MH, Gane EJ, et al. The impact of treatment of chronic hepatitis B (CHB) on patient reported outcomes (PROs). Poster 1924. AASLD 2017. Hepatology; 66:1020A, 2017.
Lau A, Joshi A, Nguyen AH, Gaggar A, Patterson SD, Woo J. Peripheral blood immune cell profiling in virally suppressed chronic hepatitis B (CHB) patients and CHB patients not on an oral antiviral therapy. HBV International Meeting 2017.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 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
- NCT02579382
- Acronym / sponsor ID
- GS-US-283-1062
- Conditions
- Chronic Hepatitis B
- Keywords
- HBV, Hepatitis, Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 16 Jan 2017 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 18 May 2020
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 vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TDF + placebo | Placebo comparator | Drug: TDF, Drug: PlaceboMain Study Phase: Tenofovir disoproxil fumarate (TDF) 300 mg tablets orally once daily for up to 48 weeks + placebo administered orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| TDF + Vesatolimod 1 mg | Experimental | Drug: TDF, Drug: VesatolimodMain Study Phase:TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 1 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| TDF + Vesatolimod 2 mg | Experimental | Drug: TDF, Drug: VesatolimodMain Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 2 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
| TDF + Vesatolimod 4 mg | Experimental | Drug: TDF, Drug: VesatolimodMain Study Phase: TDF 300 mg tablets orally once daily for up to 48 weeks + vesatolimod 4 mg tablet orally once a week (every 7 days) for 12 doses. Optional Treatment Extension Phase: At Week 48 participants had the option to continue TDF 300 mg tablets orally once daily up to Week 144. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males or females between the ages of 18-65
- Chronic hepatitis B virus (HBV) infection
- HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening
Key exclusion criteria (6 listed)
- Extensive bridging fibrosis or cirrhosis
- Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
- Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)
- Chronic liver disease other than HBV
- Lactating or pregnant females or those that wish to become pregnant during the course of the study
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 |
|---|---|---|
| TDFAlso: Viread®300 mg tablets administered orally once daily | Drug | TDF + Vesatolimod 1 mg, TDF + Vesatolimod 2 mg, TDF + Vesatolimod 4 mg, TDF + placebo |
| VesatolimodAlso: GS-9620Tablets administered orally once a week (every 7 days) for 12 doses | Drug | TDF + Vesatolimod 1 mg, TDF + Vesatolimod 2 mg, TDF + Vesatolimod 4 mg |
| PlaceboPlacebo administered orally once a week (every 7 days) for 12 doses | Drug | TDF + placebo |
Primary outcome
Mean Change (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24
Time frame: Baseline; Week 24
The change from baseline to Week 24 in HBsAg (log10 IU/mL) was analyzed using a mixed model for repeated measures (MMRM). The model included treatment, baseline HBsAg (log10 IU/mL), baseline Hepatitis B Envelope Antigen (HBeAg) status (positive or negative), baseline alanine aminotransferase (ALT) level relative to upper limit of normal (ULN) (> 19 vs ≤ 19 IU/L for females; > 30 vs ≤ 30 IU/L for males), visit and treatment-by-visit interaction as fixed effects, and visit as a repeated measure.
22 secondary outcomes
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24
Time frame: Week 24
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48
Time frame: Week 48
Percentage of Participants With HBsAg Loss and Seroconversion at Week 24
Time frame: Week 24
Percentage of Participants With HBsAg Loss and Seroconversion at Week 48
Time frame: Week 48
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 12
Time frame: Baseline; Week 12
Mean Change (Measured in log10 IU/mL) in HBsAg From Baseline at Week 48
Time frame: Baseline; Week 48
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 12
Time frame: Baseline to Week 12
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 24
Time frame: Baseline to Week 24
Percentage of Participants With a ≥ 0.5 log10 IU/mL Decline in Serum HBsAg Titers From Baseline at Week 48
Time frame: Baseline to Week 48
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) < Lower Limit of Quantitation (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
Time frame: Weeks 24 and 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase/Reverse Transcriptase (Pol/RT)
Time frame: Baseline; Week 48
Pharmacokinetic (PK) Parameter: AUClast of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: AUCinf of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: %AUCexp of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Cmax of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Clast of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tmax of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: Tlast of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: T1/2 of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
PK Parameter: CL/F of Vesatolimod
Time frame: Week 11: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29851204Agarwal K, Ahn SH, Elkhashab M, Lau AH, Gaggar A, Bulusu A, Tian X, Cathcart AL, Woo J, Subramanian GM, Andreone P, Kim HJ, Chuang WL, Nguyen MH. Safety and efficacy of vesatolimod (GS-9620) in patients with chronic hepatitis B who are not currently on antiviral treatment. J Viral Hepat. 2018 Nov;25(11):1331-1340. doi: 10.1111/jvh.12942. Epub 2018 Aug 22.
- Results publicationYounossi ZM, Stepanova M, Janssen H, Agarwal K, Nguyen MH, Gane EJ, et al. The impact of treatment of chronic hepatitis B (CHB) on patient reported outcomes (PROs). Poster 1924. AASLD 2017. Hepatology; 66:1020A, 2017.
- Results publicationLau A, Joshi A, Nguyen AH, Gaggar A, Patterson SD, Woo J. Peripheral blood immune cell profiling in virally suppressed chronic hepatitis B (CHB) patients and CHB patients not on an oral antiviral therapy. HBV International Meeting 2017.
- Individual participant dataSharing planned: No
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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
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDF and Vesatolimod in people with Chronic Hepatitis B, run by Gilead Sciences at 21 sites in 8 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 3 inclusion and 6 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Italy, South Korea, Taiwan, Canada and 3 more countries. 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. Some participants in this study may receive a placebo. 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 18 May 2020). 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 (Measured in log10 IU/mL) in Hepatitis B Surface Antigen (HBsAg) From Baseline at Week 24 (time frame: Baseline; 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 NCT02579382, 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 18 May 2020.