Back to resultsDose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NVR 3-778
Placebo for NVR 3-778
Pegasys
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Hepatitis B
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Active Comparator
Arm Label
NVR 3-778
Placebo for NVR 3-778
NVR 3-778 and Pegasys
Pegasys
Arm Description
NVR 3-778 in varying doses of capsules by mouth for 28 days
Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days
NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Outcomes
Primary Outcome Measures
Compared with baseline, decline of serum HBV-DNA in the value
Secondary Outcome Measures
Full Information
NCT ID
NCT02401737
First Posted
March 11, 2015
Last Updated
October 16, 2017
Sponsor
Novira Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02401737
Brief Title
Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 31, 2015 (Actual)
Primary Completion Date
May 18, 2016 (Actual)
Study Completion Date
May 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novira Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NVR 3-778
Arm Type
Experimental
Arm Description
NVR 3-778 in varying doses of capsules by mouth for 28 days
Arm Title
Placebo for NVR 3-778
Arm Type
Placebo Comparator
Arm Description
Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days
Arm Title
NVR 3-778 and Pegasys
Arm Type
Experimental
Arm Description
NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days
Arm Title
Pegasys
Arm Type
Active Comparator
Arm Description
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Intervention Type
Drug
Intervention Name(s)
NVR 3-778
Intervention Type
Drug
Intervention Name(s)
Placebo for NVR 3-778
Intervention Description
Sugar pill manufactured to mimic the NVR 3-778 capsule
Intervention Type
Drug
Intervention Name(s)
Pegasys
Other Intervention Name(s)
peginterferon alfa-2a
Primary Outcome Measure Information:
Title
Compared with baseline, decline of serum HBV-DNA in the value
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Costa Mesa
State/Province
California
Country
United States
City
Pasadena
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Hong Kong
Country
China
City
Chuncheon
Country
Korea, Republic of
City
Seongnam
Country
Korea, Republic of
City
Singapore
Country
Singapore
City
Kaohsiung
Country
Taiwan
City
Keelung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30625297
Citation
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.
Results Reference
derived
Learn more about this trial
Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
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