For virally-suppressed patients with Chronic Hepatitis B, will GS-9620 as compared to placebo be safer, better tolerated and more efficacious?

Gilead Sciences, Inc.0 sites150 target enrollmentJune 13, 2014

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Gilead Sciences, Inc.
Enrollment: 150
Status: Not yet recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 13, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Gilead Sciences, Inc.

Eligibility Criteria

Inclusion Criteria

•Patients must meet all of the following inclusion criteria to be eligible to participate in the study.
•1\. Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
•2\. Adult male and non\-pregnant, non\-lactating female subjects, (lactating females must agree to discontinue nursing before the study drug is administered), 18–65 years of age inclusive based on the date of the screening visit
•3\. A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post\-menopausal).
•4\. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
•5\. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months) with detectable HBsAg levels at screening
•6\. Have been on approved HBV OAV treatment for greater than or equal to 1 year prior to screening, with HBV DNA below LLOQ (measured at least once) 6 or more months prior to screening, and HBV DNA \< 20 IU/ml at screening
•7\. Subjects 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
•8\. Willing to provide blood sample for TLR\-7 and IL28B SNP assessment
•9\. Must be willing and able to comply with all study requirements

Exclusion Criteria

•Patients who meet any of the following exclusion criteria are not to be enrolled in the study:
•1\. Extensive bridging fibrosis or cirrhosis as defined clinically, by imaging or by the following:
•a) Metavir greater than or equal to 3 or Ishak fibrosis score greater than or equal to 4 by a liver biopsy within 5 years of screening. or, in the absence of an appropriate liver biopsy, either
•b) Screening FibroTest score of \> 0\.48 and APRI \> 1, or
•c) Historic FibroScan with a result \> 9 kPa within less than than or equal to 6 months of screening (if available)
•If liver biopsy is available, the liver biopsy result supersedes (b) and/or (c, if available).
•If an appropriate liver biopsy is not available, fibrosis will be evaluated by (b) and/or (c, if available). In the event of discordance between (b) and (c), the FibroScan results will take precedence.
•2\. Patients meeting any of the following laboratory parameters at screening:
•\- White Blood cell count \< 2500 IU/Ml
•\- Neutrophil count \< 1500 cell/ mm3 (or \< 1000 cell/ mm3 if considered a physiological variant in a subject of African descent)