Chronic Hepatitis BPhase 2NCT03434353

Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)

A Phase 2 study testing Inarigivir Soproxil and TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 13 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chronic Hepatitis B
What is being tested?: Inarigivir Soproxil and TAF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 13 sitesin 2 countries
Study dates: 28 Feb 2018to 26 Jan 2021
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Groups 1-3 and 5:
Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment
Group 4:
HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
Have been on a commercially available HBV NUC treatment(s)

Who cannot join

Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
Extensive bridging fibrosis or cirrhosis
Evidence of hepatocellular carcinoma on imaging
Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
Chronic liver disease of a non-HBV etiology
Current alcohol or substance abuse
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

South Korea10 sites

Korea University Ansan Hospital
Ansan, 425-707
Keimyung University Dongsan Medical Center
Daegu, 41931
Kyungpook National University Hospital
Daegu, 41944
Inje University Ilsan Paik Hospital
Ilsan, 10380
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul, 06591
SMG-SNU Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 08308

Other trials in South Korea

Hong Kong3 sites

Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Prince Margaret Hospital
Hong Kong
Prince of Wales Hospital-HK
Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects

The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

Conditions: Chronic Hepatitis B
Being tested: Inarigivir Soproxil, TAF
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.

Inarigivir SoproxilDrug
Also called SB 9200, GS-9992
Administered orally once daily one hour before or one hour after a meal
TAFDrug
Also called GS-7340, Vemlidy®
Administered orally once daily with food

Study groups in NCT03434353
Study group	Role	What they receive
Group 1: Inarigivir Soproxil 50 mg + TAF	Experimental	Viremic participants will be administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. Receives: Drug: Inarigivir Soproxil; Drug: TAF
Group 2: TAF	Experimental	Viremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks. Receives: Drug: TAF
Group 3: Inarigivir Soproxil 200 mg + TAF	Experimental	Viremic participants will be administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks Receives: Drug: Inarigivir Soproxil; Drug: TAF
Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs	Experimental	Virally suppressed participants receiving commercially available nucleoside/nucleotide (NUC) will be administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants will continue commercially available NUCs for 48 weeks. Receives: Drug: Inarigivir Soproxil
Group 5: Inarigivir Soproxil 400 mg + TAF	Experimental	Viremic participants will be administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. Receives: Drug: Inarigivir Soproxil; Drug: TAF

What is being measured

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

Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)
Measured: Baseline, Week 12
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Measured: Baseline, Week 12

Secondary outcomes (11)

Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)
Measured: Baseline, Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Measured: Baseline, Week 12
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Measured: Baseline, Weeks 12, 24, 36, and 48
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
Measured: Baseline, Weeks 12, 24, 36, and 48
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss.
Measured: Baseline, Weeks 12, 24, 36, and 48
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit.
Measured: Baseline, Weeks 12, 24, 36, and 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)
Measured: Baseline, Week 48
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)
Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits
Measured: Baseline up to Week 12
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Measured: Baseline, Weeks 12, 16, 24, 36, and 48
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Measured: Baseline, Weeks 12, 16, 24, 36, and 48
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Measured: Baseline, Weeks 12, 16, 24, 36, and 48

Timeline

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

28 Feb 201826 Jan 2021

First posted15 Feb 2018
Study start28 Feb 2018
Primary completion20 Jan 2020
Study completion26 Jan 2021

Why it stopped: Study was terminated due to sponsor's decision to not pursue further development of inarigivir soproxil in chronic hepatitis B.

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 (1)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: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03434353
Sponsor's protocol ID: GS-US-464-4437
Status last verified: Mar 2022
First submitted: 9 Feb 2018
Last updated: 4 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lim YS, Hui AJ, Jang JW, Tak WY, Ahn SH, Jang BK, et al. Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a phase 2 collaboration study [Abstract PO-2422]. The International Liver Congress: European Association for the Study of the Liver (EASL) Virtual; 2021 23-26 June.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects
ClinicalTrials.gov ID: NCT03434353
Acronym / sponsor ID: GS-US-464-4437
Conditions: Chronic Hepatitis B
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated due to sponsor's decision to not pursue further development of inarigivir soproxil in chronic hepatitis B.
Enrolment: 123 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Collaborators: F-star Therapeutics, Inc.
Study start: 28 Feb 2018 (actual)
Primary completion: 20 Jan 2020 (actual)
Study completion: 26 Jan 2021 (actual)
First posted: 15 Feb 2018 (actual)
Results: Posted 4 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1: Inarigivir Soproxil 50 mg + TAF	Experimental	Drug: Inarigivir Soproxil, Drug: TAFViremic participants will be administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks.
Group 2: TAF	Experimental	Drug: TAFViremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks.
Group 3: Inarigivir Soproxil 200 mg + TAF	Experimental	Drug: Inarigivir Soproxil, Drug: TAFViremic participants will be administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks
Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs	Experimental	Drug: Inarigivir SoproxilVirally suppressed participants receiving commercially available nucleoside/nucleotide (NUC) will be administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants will continue commercially available NUCs for 48 weeks.
Group 5: Inarigivir Soproxil 400 mg + TAF	Experimental	Drug: Inarigivir Soproxil, Drug: TAFViremic participants will be administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Groups 1-3 and 5:
Group 4:

Key exclusion criteria (7 listed)

Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
Extensive bridging fibrosis or cirrhosis
Evidence of hepatocellular carcinoma on imaging
Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
Chronic liver disease of a non-HBV etiology

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
Inarigivir SoproxilAlso: SB 9200, GS-9992Administered orally once daily one hour before or one hour after a meal	Drug	Group 1: Inarigivir Soproxil 50 mg + TAF, Group 3: Inarigivir Soproxil 200 mg + TAF, Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs, Group 5: Inarigivir Soproxil 400 mg + TAF
TAFAlso: GS-7340, Vemlidy®Administered orally once daily with food	Drug	Group 1: Inarigivir Soproxil 50 mg + TAF, Group 2: TAF, Group 3: Inarigivir Soproxil 200 mg + TAF, Group 5: Inarigivir Soproxil 400 mg + TAF

Primary outcome

Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)
Time frame: Baseline, Week 12
Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Time frame: Baseline, Week 12

11 secondary outcomes

Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5)
Time frame: Baseline, Week 12
Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)
Time frame: Baseline, Week 12
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time frame: Baseline, Weeks 12, 24, 36, and 48
Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4)
Time frame: Baseline, Weeks 12, 24, 36, and 48
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time frame: Baseline, Weeks 12, 24, 36, and 48
Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4)
Time frame: Baseline, Weeks 12, 24, 36, and 48
Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5)
Time frame: Baseline, Week 48
Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4)
Time frame: Baseline up to Week 12
Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time frame: Baseline, Weeks 12, 16, 24, 36, and 48
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5)
Time frame: Baseline, Weeks 12, 16, 24, 36, and 48
Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4)
Time frame: Baseline, Weeks 12, 16, 24, 36, and 48

Results and safety

Results posted to the registry on 4 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Inarigivir Soproxil 50 mg + TAF	30	16
Group 2: TAF	12	9
Group 3: Inarigivir Soproxil 200 mg + TAF	30	16
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)	21	18
Group 5: Inarigivir Soproxil 400 mg + TAF	30	12

Primary outcome: Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5)

Time frame: Baseline, Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: Inarigivir Soproxil 50 mg + TAF n = 30	Group 2: TAF n = 12	Group 3: Inarigivir Soproxil 200 mg + TAF n = 30	Group 5: Inarigivir Soproxil 400 mg + TAF n = 30
Value	23.3 (9.9 to 42.3)	25.0 (5.5 to 57.2)	0 (0.0 to 11.6)	6.7 (0.8 to 22.1)

Group 1: Inarigivir Soproxil 50 mg + TAF vs Group 2: TAF: Percentage Difference: -2.0 (95% CI -30.4 to 26.4)
Group 2: TAF vs Group 3: Inarigivir Soproxil 200 mg + TAF: Percentage Difference: -24.7 (95% CI -49.2 to -0.2)
Group 2: TAF vs Group 5: Inarigivir Soproxil 400 mg + TAF: Percentage Difference: -17.8 (95% CI -43.7 to 8.2)

Population analysed: The Full Analysis Set included all participants who were randomized to Groups 1 or 2, or enrolled in Group 3 and 5, and who took at least 1 dose of any study drug.

Primary outcome: Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4)

Time frame: Baseline, Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) n = 21
Value	0 (0.0 to 16.1)

Population analysed: The Full Analysis Set (Group 4) included all participants who were enrolled in Group 4, and who took at least 1 dose of any study drug.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Inarigivir Soproxil 50 mg + TAF	1 of 30 (3.3%)	8 of 30 (26.7%)	0 of 30
Group 2: TAF	1 of 12 (8.3%)	7 of 12 (58.3%)	0 of 12
Group 3: Inarigivir Soproxil 200 mg + TAF	1 of 30 (3.3%)	15 of 30 (50%)	0 of 30
Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s)	0 of 21 (0%)	9 of 21 (42.9%)	0 of 21
Group 5: Inarigivir Soproxil 400 mg + TAF	1 of 30 (3.3%)	9 of 30 (30%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationLim YS, Hui AJ, Jang JW, Tak WY, Ahn SH, Jang BK, et al. Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a phase 2 collaboration study [Abstract PO-2422]. The International Liver Congress: European Association for the Study of the Liver (EASL) Virtual; 2021 23-26 June.
Individual participant dataSharing planned: No

Related trials for Chronic Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Chronic Hepatitis B

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

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inarigivir Soproxil and TAF in people with Chronic Hepatitis B, run by Gilead Sciences at 13 sites in 2 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea, Hong Kong. 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 Apr 2022). 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 ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5) (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. 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 NCT03434353, which also lists 1 linked publication.

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 Apr 2022.