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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVR 3-778 | Experimental | NVR 3-778 in varying doses of capsules by mouth for 28 days |
|
| Placebo for NVR 3-778 | Placebo Comparator | Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days |
|
| NVR 3-778 and Pegasys | Experimental | NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days |
|
| Pegasys | Active Comparator | Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVR 3-778 | Drug |
| ||
| Placebo for NVR 3-778 |
| Measure | Description | Time Frame |
|---|---|---|
| Compared with baseline, decline of serum HBV-DNA in the value | Up to 28 days |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Costa Mesa | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30625297 | Derived | 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. |
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| Drug |
Sugar pill manufactured to mimic the NVR 3-778 capsule |
|
| Pegasys | Drug |
|
|
| 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 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000630862 | NVR 3-778 |
| C100416 | peginterferon alfa-2a |
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