Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients

October 16, 2017 updated by: Novira Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
    • Waikato
      • Hamilton, Waikato, New Zealand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVR 3-778
NVR 3-778 in varying doses of capsules by mouth for 1 day, 14 days, or 28 days
Drug: NVR 3-778
Placebo Comparator: Placebo for NVR 3-778
Placebo for NVR 3-778 in varying doses of capsules by mouth for 1 day, 14 days, or 28 days
Drug: Placebo for NVR 3-778
Sugar pill manufactured to mimic the NVR 3-778 capsule
Experimental: NVR 3-778 and Pegasys
NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days
Drug: NVR 3-778
Drug: Pegasys
Other Names:
  • peginterferon alfa-2a
Active Comparator: Pegasys
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Drug: Pegasys
Other Names:
  • peginterferon alfa-2a

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novira Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2014

Primary Completion (Actual)

May 18, 2016

Study Completion (Actual)

May 18, 2016

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 18, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVR3-778-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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