Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT02401737
- Lead Sponsor
- Novira Therapeutics, Inc.
- Brief Summary
This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.
- Detailed Description
The Phase 1b assessments of the dose-related safety, PK, and initial antiviral efficacy of NVR 3-778 in hepatitis B patients will also be conducted at approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis B patients.
To promote objective safety and tolerance assessments during this trial, study subjects, and site personnel administering the study drug and performing the clinical assessments on the subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or placebo doses), for all treatment cohorts in the study. Study advancement to subsequent patient cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol. Also, there will be one interim review of safety data by an independent Safety Monitoring Board (SMB), as described in the protocol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NVR 3-778 and Pegasys Pegasys NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days NVR 3-778 NVR 3-778 NVR 3-778 in varying doses of capsules by mouth for 28 days Pegasys Pegasys Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days Placebo for NVR 3-778 Placebo for NVR 3-778 Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days NVR 3-778 and Pegasys NVR 3-778 NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days
- Primary Outcome Measures
Name Time Method Compared with baseline, decline of serum HBV-DNA in the value Up to 28 days
- Secondary Outcome Measures
Name Time Method