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

NCT ID: NCT02112799

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-05-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis B

Keywords

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NVR 3-778

NVR 3-778 in varying doses of capsules by mouth for 1 day, 14 days, or 28 days

Group Type EXPERIMENTAL

NVR 3-778

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo for NVR 3-778

Intervention Type DRUG

Sugar pill manufactured to mimic the NVR 3-778 capsule

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

Group Type EXPERIMENTAL

NVR 3-778

Intervention Type DRUG

Pegasys

Intervention Type DRUG

Pegasys

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

Group Type ACTIVE_COMPARATOR

Pegasys

Intervention Type DRUG

Interventions

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NVR 3-778

Intervention Type DRUG

Placebo for NVR 3-778

Sugar pill manufactured to mimic the NVR 3-778 capsule

Intervention Type DRUG

Pegasys

Intervention Type DRUG

Other Intervention Names

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peginterferon alfa-2a

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novira Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hamilton, Waikato Region, New Zealand

Site Status

Auckland, , New Zealand

Site Status

Countries

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China Singapore South Korea Taiwan United States New Zealand

References

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Yuen MF, Gane EJ, Kim DJ, Weilert F, Yuen Chan HL, Lalezari J, Hwang SG, Nguyen T, Flores O, Hartman G, Liaw S, Lenz O, Kakuda TN, Talloen W, Schwabe C, Klumpp K, Brown N. Antiviral Activity, Safety, and Pharmacokinetics of Capsid Assembly Modulator NVR 3-778 in Patients with Chronic HBV Infection. Gastroenterology. 2019 Apr;156(5):1392-1403.e7. doi: 10.1053/j.gastro.2018.12.023. Epub 2019 Jan 6.

Reference Type DERIVED
PMID: 30625297 (View on PubMed)

Other Identifiers

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NVR3-778-101

Identifier Type: -

Identifier Source: org_study_id