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)

NCT ID: NCT03434353

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2021-01-26

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Inarigivir Soproxil 50 mg + TAF

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.

Group Type: EXPERIMENTAL

Inarigivir Soproxil

Intervention Type: DRUG

Administered orally once daily one hour before or one hour after a meal

TAF

Intervention Type: DRUG

Administered orally once daily with food

Group 2: TAF

Viremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks.

Group Type: EXPERIMENTAL

TAF

Intervention Type: DRUG

Administered orally once daily with food

Group 3: Inarigivir Soproxil 200 mg + TAF

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

Group Type: EXPERIMENTAL

Inarigivir Soproxil

Intervention Type: DRUG

Administered orally once daily one hour before or one hour after a meal

TAF

Intervention Type: DRUG

Administered orally once daily with food

Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs

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.

Group Type: EXPERIMENTAL

Inarigivir Soproxil

Intervention Type: DRUG

Administered orally once daily one hour before or one hour after a meal

Group 5: Inarigivir Soproxil 400 mg + TAF

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.

Group Type: EXPERIMENTAL

Inarigivir Soproxil

Intervention Type: DRUG

Administered orally once daily one hour before or one hour after a meal

TAF

Intervention Type: DRUG

Administered orally once daily with food

Interventions

Inarigivir Soproxil

Administered orally once daily one hour before or one hour after a meal

Intervention Type: DRUG

TAF

Administered orally once daily with food

Intervention Type: DRUG

Other Intervention Names

SB 9200; GS-9992; GS-7340; Vemlidy®

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

F-star Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, , Hong Kong

Prince Margaret Hospital

Hong Kong, , Hong Kong

Prince of Wales Hospital-HK

Hong Kong, , Hong Kong

Korea University Ansan Hospital

Ansan, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Catholic University of Korea, Seoul Saint Mary's Hospital

Seoul, , South Korea

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Countries

Hong Kong; South Korea

References

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.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GS-US-464-4437

Identifier Type: -

Identifier Source: org_study_id