Trial record 16 of 434 for:    hepatitis b | Open Studies

Safety and Efficacy of GS-9620 for the Treatment of Chronic Hepatitis B Virus in Virally-Suppressed Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02166047
First received: June 16, 2014
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This study will evaluate the safety, tolerability, and efficacy of GS-9620 in virologically suppressed adults with chronic hepatitis B virus (HBV) infection who are currently being treated with oral antivirals (OAV). Participants will be randomized in 3 sequential cohorts. Within each cohort, participants will be randomized in a 1:3:3:3 ratio to placebo or one of the doses of GS-9620 (1, 2, or 4 mg) and all participants will continue on their current oral antiviral treatment for the entire duration of the study. Cohorts A, B, and C will consist of a different treatment period of 4, 8, or 12 weeks, respectively, and will be followed to Week 48. After Cohort A completes treatment, a safety review will be conducted by an external data monitoring committee prior to beginning Cohort B. Another safety review will be conducted after Cohort B completes treatment prior to beginning Cohort C.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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

Secondary Outcome Measures:
  • Proportion of participants with hepatitis B e antigen (HBeAg) loss and seroconversion at Weeks 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with HBsAg loss and seroconversion at Weeks 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Mean change in serum HBsAg from baseline to Weeks 4, 8, 12 and 48 (measured in log10 IU/mL) [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with virological breakthrough [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Virological breakthrough is defined as having HBV DNA > 69 IU/ml with confirmation > 2 weeks after the initial test in the setting of satisfactory adherence to treatment with oral antivirals.

  • Proportion of participants with drug resistance mutations at Week 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of participants with ≥ 1 log10 decline in serum HBsAg titers from baseline at Weeks 4,8,12, 24 and 48 [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo 4 Weeks (Cohort A)
Participants will receive placebo to match GS-9620 once a week for 4 weeks.
Drug: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 1 mg 4 Weeks (Cohort A)
Participants will receive GS-9620 1 mg once a week for 4 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 2 mg 4 Weeks (Cohort A)
Participants will receive GS-9620 2 mg once a week for 4 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 4 mg 4 Weeks (Cohort A)
Participants will receive GS-9620 4 mg once a week for 4 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Placebo Comparator: Placebo 8 Weeks (Cohort B)
Participants will receive placebo to match GS-9620 once a week for 8 weeks.
Drug: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 1 mg 8 Weeks (Cohort B)
Participants will receive GS-9620 1 mg once a week for 8 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 2 mg 8 Weeks (Cohort B)
Participants will receive GS-9620 2 mg once a week for 8 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 4 mg 8 Weeks (Cohort B)
Participants will receive GS-9620 4 mg once a week for 8 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Placebo Comparator: Placebo 12 Weeks (Cohort C)
Participants will receive placebo to match GS-9620 once a week for 12 weeks.
Drug: Placebo to match GS-9620
Placebo to match GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 1 mg 12 Weeks (Cohort C)
Participants will receive GS-9620 1 mg once a week for 12 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 2 mg 12 Weeks (Cohort C)
Participants will receive GS-9620 2 mg once a week for 12 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days
Experimental: GS-9620 4 mg 12 Weeks (Cohort C)
Participants will receive GS-9620 4 mg once a week for 12 weeks.
Drug: GS-9620
GS-9620 tablets administered orally every 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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; consent must be obtained prior to initiation of study procedures
  • Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months) with detectable HBsAg levels at screening
  • Have been on approved HBV OAV treatment for ≥ 1 year prior to screening, with HBV DNA below lower limit of quantitation (LLOQ), measured at least once, 6 or more months prior to screening, and HBV DNA < 20 IU/ml at screening
  • Currently taking an approved HBV OAV (tenofovir, entecavir, adefovir, lamivudine or telbivudine, either as single agents or in combination) with no change in regimen for 3 months prior to screening
  • Willing to provide blood sample for toll-like receptor 7 (TLR-7) and interleukin 28 B (IL28B) single-nucleotide polymorphism (SNP) assessment
  • Must be willing and able to comply with all study requirements

Exclusion Criteria:

  • Extensive bridging fibrosis or cirrhosis
  • Lab parameters not within defined thresholds for neutropenia, anemia, thrombocytopenia, leukopenia, or other evidence of inadequate liver function
  • Co-infection with hepatitis C virus (HCV), HIV, or hepatitis D virus (HDV)
  • Evidence of hepatocellular carcinoma
  • Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible
  • Significant cardiovascular, pulmonary, or neurological disease
  • Any of the following conditions that may worsen in response to interferon (IFN):

    • Autoimmune disease (e.g. lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis)
    • Poorly controlled diabetes mellitus
    • Significant psychiatric disorders
    • Thyroid disorder (unless controlled under treatment)
    • Significant pulmonary diseases (e.g. chronic obstructive pulmonary disease)
    • Retinal disease
    • Immunodeficiency disorders
  • 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 another investigational agents within 3 months of screening
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
  • Females who are pregnant or may wish to become pregnant during 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: NCT02166047

Contacts
Contact: Gilead Study Team TLR7-9620@gilead.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90095
Recruiting
San Diego, California, United States, 92154
Recruiting
San Francisco, California, United States, 94118
Active, not recruiting
San Jose, California, United States, 95128
United States, Hawaii
Recruiting
Honolulu, Hawaii, United States, 96734
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02111
Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Not yet recruiting
Flushing, New York, United States, 11355
Canada, Alberta
Withdrawn
Edmonton, Alberta, Canada, T6G2X8
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Recruiting
Toronto, Ontario, Canada, M5G2C4
Recruiting
Toronto, Ontario, Canada, M5T 2S8
Italy
Not yet recruiting
San Giovanni Rotondo, FG, Italy, 71013
Not yet recruiting
Milan, Italy, 20122
Not yet recruiting
Parma, Italy, 43126
Not yet recruiting
Pisa, Italy, 56124
Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of, 120-752
Not yet recruiting
Seoul, Korea, Republic of, 110-744
Not yet recruiting
Seoul, Korea, Republic of, 138-736
Not yet recruiting
Seoul, Korea, Republic of, 135-710
Netherlands
Not yet recruiting
Rotterdam, Netherlands, 3015 CE
New Zealand
Recruiting
Auckland, New Zealand, 1142
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Benedetta Massetto, MD, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02166047     History of Changes
Other Study ID Numbers: GS-US-283-1059, 2014-001400-22
Study First Received: June 16, 2014
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Canada: Health Canada
Italy: The Italian Medicines Agency
New Zealand: Medsafe
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Gilead Sciences:
Hepatitis B
HBV
GS-9620
TLR-7 Agonist

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 28, 2014