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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novira Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Novira Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02112799
First received: April 9, 2014
Last updated: September 8, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 112
Study Start Date: April 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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 subcutaenous 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 4 different sites to meet enrollment goals of 72-84 chronic hepatitis B patients.

Study treatment in Parts I and II will be randomized and double-blinded. The volunteers in each Part I dose cohort will be randomized 6:2 with active NVR 3-778 doses or matching placebo doses. Similarly, study treatment for each cohort in Part II will be randomized 10:2 to treatment with active NVR 3-778 doses or matching placebo doses.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112799

Contacts
Contact: Sandy Liaw sliaw@noviratherapeutics.com

Locations
China
Not yet recruiting
Hong Kong, China
New Zealand
Not yet recruiting
Hamilton, Waikato, New Zealand
Recruiting
Auckland, New Zealand
Singapore
Not yet recruiting
Singapore, Singapore
Sponsors and Collaborators
Novira Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Novira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02112799     History of Changes
Other Study ID Numbers: NVR3-778-101(B)
Study First Received: April 9, 2014
Last Updated: September 8, 2014
Health Authority: New Zealand: Medsafe

Keywords provided by Novira Therapeutics, Inc.:
hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014