Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
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
1 other identifier
interventional
58
5 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2015
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2015
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2016
CompletedOctober 18, 2017
October 1, 2017
1.3 years
March 11, 2015
October 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compared with baseline, decline of serum HBV-DNA in the value
Up to 28 days
Study Arms (4)
NVR 3-778
EXPERIMENTALNVR 3-778 in varying doses of capsules by mouth for 28 days
Placebo for NVR 3-778
PLACEBO COMPARATORPlacebo for NVR 3-778 in varying doses of capsules by mouth for 28 days
NVR 3-778 and Pegasys
EXPERIMENTALNVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days
Pegasys
ACTIVE COMPARATORPegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Interventions
Sugar pill manufactured to mimic the NVR 3-778 capsule
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Pasadena, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Hong Kong, China
Unknown Facility
Singapore, Singapore
Unknown Facility
Chuncheon, South Korea
Unknown Facility
Seongnam, South Korea
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Keelung, Taiwan
Related Publications (1)
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.
PMID: 30625297DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 30, 2015
Study Start
January 31, 2015
Primary Completion
May 18, 2016
Study Completion
May 18, 2016
Last Updated
October 18, 2017
Record last verified: 2017-10