Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
NCT ID: NCT02401737
Last Updated: 2017-10-18
Study Results
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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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2015-01-31
2016-05-18
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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NVR 3-778
NVR 3-778 in varying doses of capsules by mouth for 28 days
NVR 3-778
Placebo for NVR 3-778
Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days
Placebo for NVR 3-778
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
NVR 3-778
Pegasys
Pegasys
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Pegasys
Interventions
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NVR 3-778
Placebo for NVR 3-778
Sugar pill manufactured to mimic the NVR 3-778 capsule
Pegasys
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Novira Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Costa Mesa, California, United States
Pasadena, California, United States
San Diego, California, United States
San Francisco, California, United States
Hong Kong, , China
Singapore, , Singapore
Chuncheon, , South Korea
Seongnam, , South Korea
Kaohsiung City, , Taiwan
Keelung, , Taiwan
Countries
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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.
Other Identifiers
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NVR3-778-101B
Identifier Type: -
Identifier Source: org_study_id