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 April 2014
End date May 2016
Trial size 84 participants
Trial identifier NCT02112799, NVR3-778-101


This Phase 1 trial will assess the dose-related safety and PK profile of different doses of NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with chronic hepatitis B (part II). Additionally, in Part II, 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 1 day, 14 days, or 28 days
nvr 3-778
(Placebo Comparator)
Placebo for NVR 3-778 in varying doses of capsules by mouth for 1 day, 14 days, or 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

To assess the dose-related safety and tolerability of NVR 3-778 in healthy volunteers and hepatitis B patients
time frame: Up to 28 days

Eligibility Criteria

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

Healthy volunteers may be male or female between 18 and 65 years old with a BMI of 18-32kg/m2. They must be in good health not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study. Patients enrolling in Part II of the study, may be male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2. Patients must have HBeAg positive, chronic hepatitis B with no history of clinical decompensation, and must not have been treated for hepatitis B before.

Additional Information

Official title A Phase 1 Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Initial Antiviral Efficacy of NVR 3-778 in Healthy Volunteers and Patients With Chronic Hepatitis B
Description The Part I (Phase 1a) assessments of the dose-related safety and PK of NVR 3-778 in volunteers will be conducted an established Phase 1 unit, which will facilitate the overnight confinements and frequent safety assessments and blood sampling required for the Part I evaluations. The Part II (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 volunteer cohorts in Part I and subsequent patient cohorts in Part II will require satisfactory interim reviews of available cumulative safety data by the Part I and Part II Safety Review Committees (SRCs), using the safety criteria and review procedures described in the protocol. Also, there will be two interim reviews 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..