Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients

Novira Therapeutics

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Pegasys; Drug: NVR 3-778; Drug: Placebo for NVR 3-778

Study type: Interventional

Funder types: Industry

Identifiers

NCT02401737

NVR3-778-101B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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58 participants in 4 patient groups, including a placebo group

NVR 3-778

Experimental group

Description:

NVR 3-778 in varying doses of capsules by mouth for 28 days

Treatment:

Drug: NVR 3-778

Placebo for NVR 3-778

Placebo Comparator group

Description:

Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days

Treatment:

Drug: Placebo for NVR 3-778

NVR 3-778 and Pegasys

Experimental group

Description:

NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days

Treatment:

Drug: NVR 3-778

Drug: Pegasys

Pegasys

Active Comparator group

Description:

Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days

Treatment:

Drug: Pegasys