Trial record 38 of 506 for:    hepatitis b | Open Studies

A Study of the Safety, Tolerability, and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02579382
First received: October 15, 2015
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
The study will evaluate the safety, tolerability, and efficacy of GS-9620 in adults with chronic hepatitis B (CHB) infection who are currently not being treated.

Condition Intervention Phase
Chronic Hepatitis B
Drug: TDF
Drug: GS-9620
Drug: GS-9620 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Mean change (measured in log10 IU/mL) in serum hepatitis B surface antigen (HBsAg) from baseline [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of participants with hepatitis B e antigen (HBeAg) loss and seroconversion [ Time Frame: Baseline, Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportions of participants with HBsAg loss and seroconversion [ Time Frame: Baseline, Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Mean change (measured in log10 IU/mL) in HBsAg from baseline [ Time Frame: Baseline, Weeks 12 and 48 ] [ Designated as safety issue: No ]
  • Proportions of participants with a ≥ 0.5 log10 IU/mL decline in serum HBsAg titers from baseline [ Time Frame: Baseline, Weeks 12, 24, and 48 ] [ Designated as safety issue: No ]
  • Proportions of participants with hepatitis B virus (HBV) DNA < lower limit of quantitation (LLOQ) at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Proportion of subject experiencing virologic breakthrough [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
  • Proportion of participant with drug resistance mutations [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) Parameter: AUClast of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  • PK Parameter: AUCinf of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    AUCinf is defined as the concentration of drug extrapolated to infinite time.

  • PK Parameter: %AUCexp of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    %AUCexp is defined as the percentage of AUC extrapolated between AUClast and AUCinf.

  • PK Parameter: Cmax of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    Cmax is defined as the maximum concentration of drug.

  • PK Parameter: Clast of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    Clast is defined as the last observable concentration of drug.

  • PK Parameter: Tmax of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    Tmax is defined as the time (observed time point) of Cmax

  • PK Parameter: Tlast of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    Tlast is defined as the time (observed time point) of Clast.

  • PK Parameter: T1/2 of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    T1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  • PK Parameter: CL/F of GS-9620 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
    CL/F is defined as the apparent oral clearance following administration of the drug.


Estimated Enrollment: 175
Study Start Date: November 2015
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: TDF + placebo
TDF + placebo to match GS-9620
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Name: Viread®
Drug: GS-9620 Placebo
Placebo to match GS-9620 administered orally once a week (every 7 days) for 12 doses
Experimental: TDF + GS-9620 1 mg
TDF + GS-9620 1 mg
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Name: Viread®
Drug: GS-9620
GS-9620 tablets administered orally once a week (every 7 days) for 12 doses
Experimental: TDF + GS-9620 2 mg
TDF + GS-9620 2 mg
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Name: Viread®
Drug: GS-9620
GS-9620 tablets administered orally once a week (every 7 days) for 12 doses
Experimental: TDF + GS-9620 4 mg
TDF + GS-9620 4 mg
Drug: TDF
TDF 300 mg tablets administered orally once daily
Other Name: Viread®
Drug: GS-9620
GS-9620 tablets administered orally once a week (every 7 days) for 12 doses

  Eligibility

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

Inclusion Criteria:

  • Adult males or females between the ages of 18-65
  • Chronic HBV infection
  • HBV DNA ≥ 2000 IU/mL at screening

Exclusion Criteria:

  • Extensive bridging fibrosis or cirrhosis
  • Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
  • Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
  • Chronic liver disease other than HBV
  • Lactating or pregnant females or those that wish to become pregnant during the course of the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02579382

Contacts
Contact: Gilead Study Team 283-1062@gilead.com

Locations
United States, California
Active, not recruiting
Los Angeles, California, United States
Active, not recruiting
Palo Alto, California, United States
Active, not recruiting
San Diego, California, United States
Active, not recruiting
San Francisco, California, United States
United States, Hawaii
Active, not recruiting
Honolulu, Hawaii, United States
United States, Maryland
Active, not recruiting
Catonsville, Maryland, United States
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States
United States, New York
Active, not recruiting
Flushing, New York, United States
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States
Canada, Ontario
Active, not recruiting
Toronto, Ontario, Canada
Italy
Active, not recruiting
Bologna, Italy
Active, not recruiting
Milano, Italy
Active, not recruiting
Pisa, Italy
Korea, Republic of
Active, not recruiting
Daegu, Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of
Active, not recruiting
Yangsan, Korea, Republic of
New Zealand
Active, not recruiting
Grafton, Auckland, New Zealand
Taiwan
Active, not recruiting
Kaohsiung, Taiwan
United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Audrey Lau, MD Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02579382     History of Changes
Other Study ID Numbers: GS-US-283-1062  2015-002017-30 
Study First Received: October 15, 2015
Last Updated: June 21, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Italy: The Italian Medicines Agency
Hong Kong: Department of Health
New Zealand: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Gilead Sciences:
HBV
Hepatitis
Liver Disease

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

ClinicalTrials.gov processed this record on July 26, 2016