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NCT02401737 Clinical Trial

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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02401737
Other study ID # NVR3-778-101B
Secondary ID
Status Completed
Phase Phase 1
First received March 11, 2015
Last updated October 16, 2017
Start date January 31, 2015
Est. completion date May 18, 2016

Study information
Verified date October 2017
Source Novira Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 58
Est. completion date May 18, 2016
Est. primary completion date May 18, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NVR 3-778

• Placebo for NVR 3-778
Sugar pill manufactured to mimic the NVR 3-778 capsule
• Pegasys

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novira Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  China,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compared with baseline, decline of serum HBV-DNA in the value Up to 28 days
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