This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments nvr 3-778, placebo for nvr 3-778, pegasys
Phase phase 1
Sponsor Novira Therapeutics, Inc.
Start date January 2015
End date March 2016
Trial size 84 participants
Trial identifier NCT02401737, NVR3-778-101B


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
NVR 3-778 in varying doses of capsules by mouth for 28 days
nvr 3-778
(Placebo Comparator)
Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days
placebo for nvr 3-778
Sugar pill manufactured to mimic the NVR 3-778 capsule
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
pegasys peginterferon alfa-2a
(Active Comparator)
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
pegasys peginterferon alfa-2a

Primary Outcomes

Compared with baseline, decline of serum HBV-DNA in the value
time frame: Up to 28 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Patients may be male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2. Patients must be HBeAg positive and have chronic hepatitis B with no history of clinical decompensation.

Additional Information

Official title A Phase 1b Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Initial Antiviral Efficacy of NVR 3-778 in Patients With HBeAg-Positive Chronic Hepatitis B Virus Infection
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novira Therapeutics, Inc..