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Trial record 31 of 325 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adults With Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT03491553
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of multiple oral doses of GS-9688 in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: GS-9688 Drug: Placebo Drug: OAV Therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hepatitis B e antigen (HBeAg)-positive CHB, Placebo
Participants will remain on their current OAV and receive placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until the end of study (Week 48/Early Discontinuation [ED]).
Drug: Placebo
Placebo to match (PTM) GS-9688 tablet(s) administered orally once weekly
Drug: OAV Therapy
Commercially available HBV OAV treatment(s)
Experimental: HBeAg-positive CHB, GS-9688 1.5 mg
Participants will remain on their current OAV and receive GS-9688 1.5 mg (1 x 1.5 mg tablet) plus placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until the end of study (Week 48/ED).
Drug: GS-9688
Tablet(s) administered orally once weekly
Drug: Placebo
Placebo to match (PTM) GS-9688 tablet(s) administered orally once weekly
Drug: OAV Therapy
Commercially available HBV OAV treatment(s)
Experimental: HBeAg-positive CHB, GS-9688 3 mg
Participants will remain on their current OAV and receive GS-9688 3 mg (2 x 1.5 mg tablet) for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until the end of study (Week 48/ED).
Drug: GS-9688
Tablet(s) administered orally once weekly
Drug: OAV Therapy
Commercially available HBV OAV treatment(s)
Experimental: HBeAg-negative CHB, Placebo
Participants will remain on their current OAV and receive placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until the end of study (Week 48/ED).
Drug: Placebo
Placebo to match (PTM) GS-9688 tablet(s) administered orally once weekly
Drug: OAV Therapy
Commercially available HBV OAV treatment(s)
Experimental: HBeAg-negative CHB, GS-9688 1.5 mg
Participants will remain on their current OAV and receive GS-9688 1.5 mg (1 x 1.5 mg tablet) plus placebo for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until the end of study (Week 48/ED).
Drug: GS-9688
Tablet(s) administered orally once weekly
Drug: Placebo
Placebo to match (PTM) GS-9688 tablet(s) administered orally once weekly
Drug: OAV Therapy
Commercially available HBV OAV treatment(s)
Experimental: HBeAg-negative CHB, GS-9688 3 mg
Participants will remain on their current OAV and receive GS-9688 3 mg (2 x 1.5 mg tablet) for 24 doses. After the 24th dose, participants will continue on their current OAV therapy until the end of study (Week 48/ED).
Drug: GS-9688
Tablet(s) administered orally once weekly
Drug: OAV Therapy
Commercially available HBV OAV treatment(s)



Primary Outcome Measures :
  1. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 4 [ Time Frame: Baseline to Week 4 ]
  2. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 8 [ Time Frame: Baseline to Week 8 ]
  3. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 12 [ Time Frame: Baseline to Week 12 ]
  4. Proportion of Participants With ≥ 1 Log10 IU/mL Decline in qHBsAg From Baseline at Week 48 [ Time Frame: Baseline to Week 48 ]
  5. Change in qHBsAg (log10 IU/mL) From Baseline at Week 4 [ Time Frame: Baseline to Week 4 ]
  6. Change in qHBsAg (log10 IU/mL) From Baseline at Week 8 [ Time Frame: Baseline to Week 8 ]
  7. Change in qHBsAg (log10 IU/mL) From Baseline at Week 12 [ Time Frame: Baseline to Week 12 ]
  8. Change in qHBsAg (log10 IU/mL) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]
  9. Change in qHBsAg (log10 IU/mL) From Baseline at Week 48 [ Time Frame: Baseline to Week 48 ]
  10. Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12 [ Time Frame: Baseline to Week 12 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  11. Proportion of Participants With HBsAg Loss at Week 24 [ Time Frame: Baseline to Week 24 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  12. Proportion of Participants With HBsAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ]
    HBsAg loss is defined as HBsAg changing from positive at baseline to negative at a postbaseline visit.

  13. Proportion of Participants With HBeAg Loss at Week 12 [ Time Frame: Baseline to Week 12 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  14. Proportion of Participants With HBeAg Loss at Week 24 [ Time Frame: Baseline to Week 24 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  15. Proportion of Participants With HBeAg Loss at Week 48 [ Time Frame: Baseline to Week 48 ]
    HBeAg loss is defined as HBeAg changing from positive at baseline to negative at a postbaseline visit.

  16. Proportion of Participants With HBeAg Seroconversion at Week 12 [ Time Frame: Baseline to Week 12 ]
    HBeAg seroconversion is defined as HBeAg loss and HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

  17. Proportion of Participants With HBeAg Seroconversion at Week 24 [ Time Frame: Baseline to Week 24 ]
    HBeAg seroconversion is defined as HBeAg loss and HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

  18. Proportion of Participants With HBeAg Seroconversion at Week 48 [ Time Frame: Baseline to 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.

  19. Proportion of Participants with Virologic Breakthrough [ Time Frame: Up to 48 Weeks ]
    Virologic breakthrough is defined as two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL

  20. Proportion of Participants With Drug Resistance Mutations [ Time Frame: Up to 48 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Adult males and non-pregnant, non-lactating females
  • Documented evidence of chronic HBV infection with detectable HBsAg levels
  • On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening
  • HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening
  • Screening Electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

  • Extensive bridging fibrosis or cirrhosis
  • Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:

    • Alanine aminotransferase (ALT) >3x Upper Limit of Normal (ULN)
    • International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen
    • Albumin < 3.5 g/dL
    • Direct bilirubin >1.5x ULN
    • Platelet Count < 100,000/uL
    • Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)
  • Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus
  • Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging
  • Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.
  • Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease
  • Received solid organ or bone marrow transplant
  • Received prolonged therapy with immunomodulators or biologics within 3 months of screening
  • Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor

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): NCT03491553


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

Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03491553     History of Changes
Other Study ID Numbers: GS-US-389-2024
ACTRN12618000143224p ( Registry Identifier: ANZCTR )
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Antiviral Agents
Anti-Infective Agents