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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02112799
First Posted: April 14, 2014
Last Update Posted: March 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novira Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis B Drug: NVR 3-778 Drug: Placebo for NVR 3-778 Drug: Pegasys Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novira Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: April 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: peginterferon alfa-2a
Active Comparator: Pegasys
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Drug: Pegasys
Other Name: peginterferon alfa-2a

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112799


Locations
New Zealand
Hamilton, Waikato, New Zealand
Auckland, New Zealand
Sponsors and Collaborators
Novira Therapeutics, Inc.
  More Information

Responsible Party: Novira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02112799     History of Changes
Other Study ID Numbers: NVR3-778-101
First Submitted: April 9, 2014
First Posted: April 14, 2014
Last Update Posted: March 7, 2016
Last Verified: March 2016

Keywords provided by Novira Therapeutics, Inc.:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs


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