Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434353
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Spring Bank Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir (GS-9992) 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 plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir with commercially available NUC(s) in virally suppressed CHB participants (Group 4).

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Inarigivir Drug: TAF Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: Group 1 (Inarigivir 50 mg + TAF)
Inarigivir 50 mg (2 x 25 mg capsule) plus TAF for 12 weeks, followed by TAF for 36 weeks
Drug: Inarigivir
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992

Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®

Experimental: Group 2 (TAF)
TAF for 48 weeks
Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®

Experimental: Group 3 (Inarigivir 200 mg + TAF)
Inarigivir 200 mg (2 x 100 mg tablet) plus TAF for 12 weeks, followed by TAF for 36 weeks
Drug: Inarigivir
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992

Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®

Experimental: Group 4 (Inarigivir 100 mg)
Inarigivir 100 mg tablet for 12 weeks in virally suppressed participants currently being treated with a commercially available NUC
Drug: Inarigivir
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992

Experimental: Group 5 (Inarigivir 200 mg + TAF)
Inarigivir 400 mg (2 x 200 mg tablet) plus TAF for 12 weeks, followed by TAF for 36 weeks (Group 5 applies to Hong Kong only)
Drug: Inarigivir
Administered orally once daily one hour before or one hour after a meal
Other Names:
  • SB 9200
  • GS-9992

Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®




Primary Outcome Measures :
  1. Groups 1-5: Proportion of Participants With ≥ 0.5 log10 IU/mL Decline in Hepatitis B Surface Antigen (HBsAg) from Baseline at Week 12 [ Time Frame: Baseline; Week 12 ]

Secondary Outcome Measures :
  1. Groups 1-5: Proportion of Participants With ≥ 1 log10 IU/mL Decline in Hepatitis B Surface Antigen (HBsAg) from Baseline at Week 12 [ Time Frame: Baseline; Week 12 ]
  2. Groups 1-5: Proportion of HBeAg-Positive Participants who Achieve Hepatitis B e Antigen (HBeAg) Loss [ Time Frame: Baseline through Week 48 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  3. Groups 1-5: Proportion of HBeAg-Positive Participants who Achieve HBeAg Seroconversion [ Time Frame: Baseline through Week 48 ]
    HBeAg seroconversion is defined as HBeAg loss and HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

  4. Groups 1-5: Proportion of Participants who Achieve HBsAg Loss [ Time Frame: Baseline through Week 48 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  5. Groups 1-3 and 5: Proportion of Participants with Drug Resistance Mutations [ Time Frame: Baseline through Week 48 ]
  6. Groups 1-3 and 5: Change from Baseline in Hepatitis B Virus (HBV) DNA [ Time Frame: Baseline through Week 48 ]
  7. Groups 1-5: Change from Baseline in Quantitative HBsAg [ Time Frame: Baseline through Week 48 ]
  8. Group 4: Proportion of Participants Experiencing HBV Virologic Breakthrough during 12 Weeks of Inarigivir Treatment [ Time Frame: Baseline through Week 12 ]
    Virologic breakthrough is defined as having two consecutive visits of HBV deoxyribonucleic acid (DNA) ≥ 69 IU/mL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • All Groups:

    • Aged 18 to 70 years of age, inclusive, based on the date of screening visit.
    • Chronic hepatitis B infection
  • Groups 1-3 and 5:

    • Individuals not taking any prescribed HBV NUC treatment
  • Group 4:

    • HBV 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 HCV, HIV, or 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434353


Contacts
Layout table for location contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
Layout table for location information
Hong Kong
Alice Ho Miu Ling Nethersole Hospital Recruiting
Hong Kong, Hong Kong
Prince Margaret Hospital Recruiting
Hong Kong, Hong Kong
Prince of Wales Hospital-HK Recruiting
Hong Kong, Hong Kong
Korea, Republic of
Korea University Ansan Hospital Active, not recruiting
Ansan, Korea, Republic of, 425-707
Keimyung University Dongsan Medical Center Active, not recruiting
Daegu, Korea, Republic of, 41931
Kyungpook National University Hospital Active, not recruiting
Daegu, Korea, Republic of, 41944
Inje University Ilsan Paik Hospital Active, not recruiting
Ilsan, Korea, Republic of, 10380
Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital, Yonsei University Health System Active, not recruiting
Seoul, Korea, Republic of, 06273
Catholic University of Korea, Seoul Saint Mary's Hospital Active, not recruiting
Seoul, Korea, Republic of, 06591
SMG-SNU Boramae Medical Center Active, not recruiting
Seoul, Korea, Republic of, 07061
Korea University Guro Hospital Active, not recruiting
Seoul, Korea, Republic of, 08308
Sponsors and Collaborators
Gilead Sciences
Spring Bank Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03434353     History of Changes
Other Study ID Numbers: GS-US-464-4437
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents