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Trial record 65 of 339 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03434353
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : May 4, 2018
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 antiviral activity, safety and tolerability of 12 weeks of GS-9992 plus tenofovir alafenamide (TAF) versus TAF alone in adults with chronic hepatitis B (CHB).

Participants will be randomized in a 3:1 ratio to Group 1 and Group 2. Group 3 is optional and may be enrolled based on emerging safety and efficacy data from ongoing Phase 2 study ACHIEVE (SB-9200-HBV-201; NCT02751996).


Condition or disease Intervention/treatment Phase
Chronic Hepatitis b Drug: GS-9992 Drug: TAF Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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 : December 2018
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Group 1 (GS-9992 + TAF)
Participants will receive 2 x 25 mg capsules GS-9992 plus TAF for 12 weeks followed by TAF for 36 weeks
Drug: GS-9992
25 mg capsule(s) administered orally once daily one hour before or one hour after morning meal
Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®
  • SB 9200
Experimental: Group 2 (TAF)
Participants will receive TAF for 48 weeks
Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®
  • SB 9200
Experimental: Optional Group 3 (GS-9992 + TAF)
Participants will receive a dose of GS-9992, less than or equal to the highest safe dose evaluated in the Phase 2 ACHIEVE (SB-9200-HBV-201; NCT02751996) study, plus TAF for 12 weeks, followed by TAF for 36 weeks
Drug: GS-9992
25 mg capsule(s) administered orally once daily one hour before or one hour after morning meal
Drug: TAF
25 mg tablet administered orally once daily with food
Other Names:
  • GS-7340
  • Vemlidy®
  • SB 9200



Primary Outcome Measures :
  1. Proportion of Participants With ≥ 0.5 log10 IU/mL Decline in Hepatitis Surface Antigen (HBsAg) from Baseline at Week 12 [ Time Frame: Week 12 ]
  2. Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 12 Weeks Plus 30 Days ]
  3. Proportion of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 12 Weeks Plus 30 Days ]

Secondary Outcome Measures :
  1. Proportion of Participants With ≥ 1 log10 IU/mL Decline in Hepatitis B Surface Antigen (HBsAg) from Baseline at Week 12 [ Time Frame: Week 12 ]
  2. 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. Proportion of HBeAg-Positive Participants who Achieve hepatitis B e antigen (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. Proportion of Participants who Achieve Hepatitis B Surface Antigen (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. Proportion of Participants with Drug Resistance Mutations [ Time Frame: Baseline through Week 48 ]
  6. Change from Baseline in Hepatitis B Virus (HBV) DNA [ Time Frame: Baseline through Week 48 ]
  7. Change from Baseline in Quantitative Hepatitis B Surface Antigen (HBsAg) [ Time Frame: Baseline through Week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Males and non-pregnant females, with chronic HBV infection not currently on HBV oral antiviral (OAV) treatment for at least 3 months, with elevated alanine aminotransferase (ALT) and elevated HBV DNA, may be eligible for the study.

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
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Korea, Republic of, 425707
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 41931
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of, 10380
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 06273
The Catholic University of Korea, Seoul Saint Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Sponsors and Collaborators
Gilead Sciences
Spring Bank Pharmaceuticals, Inc.
Investigators
Study Director: Gilead Study Director Gilead Sciences

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: May 4, 2018
Last Verified: May 2018

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:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, 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