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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03434353
Other study ID # GS-US-464-4437
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 28, 2018
Est. completion date January 26, 2021

Study information

Verified date March 2022
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 123
Est. completion date January 26, 2021
Est. primary completion date January 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key 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) Key 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Intervention

Drug:
Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
TAF
Administered orally once daily with food

Locations

Country Name City State
Hong Kong Alice Ho Miu Ling Nethersole Hospital Hong Kong
Hong Kong Prince Margaret Hospital Hong Kong
Hong Kong Prince of Wales Hospital-HK Hong Kong
Korea, Republic of Korea University Ansan Hospital Ansan
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Inje University Ilsan Paik Hospital Ilsan
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Catholic University of Korea, Seoul Saint Mary's Hospital Seoul
Korea, Republic of Gangnam Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of SMG-SNU Boramae Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Gilead Sciences F-star Therapeutics, Inc.

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of, 

References & Publications (1)

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:

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With = 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5) Baseline, Week 12
Primary Percentage of Participants With = 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) Baseline, Week 12
Secondary Percentage of Participants With = 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5) Baseline, Week 12
Secondary Percentage of Participants With = 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) Baseline, Week 12
Secondary 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. Baseline, Weeks 12, 24, 36, and 48
Secondary 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. Baseline, Weeks 12, 24, 36, and 48
Secondary 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. Baseline, Weeks 12, 24, 36, and 48
Secondary 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. Baseline, Weeks 12, 24, 36, and 48
Secondary 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) Baseline, Week 48
Secondary 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 Baseline up to Week 12
Secondary Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) Baseline, Weeks 12, 16, 24, 36, and 48
Secondary Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) Baseline, Weeks 12, 16, 24, 36, and 48
Secondary Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4) Baseline, Weeks 12, 16, 24, 36, and 48
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