Trial record 37 of 439 for:    hepatitis b | Open Studies

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02174276
First received: June 23, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

This study is to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with chronic hepatitis B infection (CHB) and who are currently not on treatment. Participants will be randomized to receive tenofovir disoproxil fumarate (TDF) alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a 3 year registry study.


Condition Intervention Phase
Chronic Hepatitis B
Drug: TDF
Biological: GS-4774
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 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 in serum hepatitis B surface antigen (HBsAg) from baseline to Week 24 (measured in log10 IU/mL) [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in serum HBsAg from baseline to Weeks 12 and 48 (measured in log10 IU/mL) [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with HBsAg loss and HBsAg seroconversion at Weeks 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with a ≥ 0.5 log10 or a ≥ 1.0 log10 decline in HBsAg at Weeks 12, 24, and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with hepatitis B e antigen (HBeAg) loss and HBeAg seroconversion at Weeks 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with hepatitis B virus (HBV) DNA < 20 IU/mL at Weeks 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportions of participants experiencing virologic breakthrough at Weeks 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
    Virologic breakthrough is defined as having confirmed HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL or HBV DNA ≥ 1 log10 IU/mL from nadir.

  • Incidence of drug resistance mutations at Week 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: June 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TDF 48 weeks
Participants will receive TDF for 48 weeks.
Drug: TDF
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily.
Other Name: Viread®
Experimental: TDF plus GS-4774 2 YU
Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks.
Drug: TDF
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily.
Other Name: Viread®
Biological: GS-4774
GS-4774 administered as a subcutaneous injection every four weeks for a total of 6 doses
Experimental: TDF plus GS-4774 10 YU
Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks.
Drug: TDF
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily.
Other Name: Viread®
Biological: GS-4774
GS-4774 administered as a subcutaneous injection every four weeks for a total of 6 doses
Experimental: TDF plus GS-4774 40 YU
Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks.
Drug: TDF
Tenofovir disoproxil fumarate (TDF) 300 mg tablets administered orally once daily.
Other Name: Viread®
Biological: GS-4774
GS-4774 administered as a subcutaneous injection every four weeks for a total of 6 doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
  • Documented evidence of chronic HBV infection (e.g., HBsAg positive for more than 6 months)
  • Screening HBV DNA ≥ 2000 IU/mL
  • A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal)

Exclusion Criteria:

  • Cirrhosis
  • Inadequate liver function
  • Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
  • Received antiviral treatment for HBV within 3 months of screening
  • Evidence of hepatocellular carcinoma (e.g., as evidenced by recent imaging)
  • Significant cardiovascular, pulmonary, or neurological disease
  • Women who are pregnant or may wish to become pregnant during the course of the study
  • Received solid organ or bone marrow transplant
  • Received prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics (e.g., monoclonal Ab, interferon) within 3 months of screening
  • Use of investigational agents within 3 months of screening
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
  • Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
  • History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
  • Documented history of yeast allergy
  • Known hypersensitivity to study drugs, metabolites or formulation excipients
  • Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
  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: NCT02174276

Contacts
Contact: Gilead Study Team GS-US-330-1401@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Anuj Gaggar, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02174276     History of Changes
Other Study ID Numbers: GS-US-330-1401, 2014-001011-39
Study First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Italy: Ministry of Health
Romania: National Medicines Agency
New Zealand: Medsafe
South Korea: Ministry of Food and Drug Safety
Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 22, 2014