Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatments||nvr 3-778, placebo for nvr 3-778, pegasys|
|Sponsor||Novira Therapeutics, Inc.|
|Start date||January 2015|
|End date||March 2016|
|Trial size||84 participants|
|Trial identifier||NCT02401737, NVR3-778-101B|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Costa Mesa, CA||not available||no longer recruiting|
|Pasadena, CA||not available||no longer recruiting|
|San Diego, CA||not available||no longer recruiting|
|San Francisco, CA||not available||no longer recruiting|
|Hong Kong, China||not available||no longer recruiting|
|Chuncheon, Korea, Republic of||not available||no longer recruiting|
|Seongnam, Korea, Republic of||not available||no longer recruiting|
|Singapore, Singapore||not available||no longer recruiting|
|Kaohsiung, Taiwan||not available||no longer recruiting|
|Keelung, Taiwan||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator)|
Compared with baseline, decline of serum HBV-DNA in the value
time frame: Up to 28 days
Male or female participants from 18 years up to 65 years old.
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.
|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|
|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.|
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