Continue Entecavir Rollover From China
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00975091
First received: September 8, 2009
Last updated: January 29, 2010
Last verified: November 2009
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Purpose
The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B Virus |
Drug: Entecavir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events [ Time Frame: Through 3 years of dosing and up to 48 weeks of off treatment follow up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort [ Time Frame: Through 3 years of dosing ] [ Designated as safety issue: No ]
| Enrollment: | 600 |
| Study Start Date: | May 2004 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Entecavir 0.5 |
Drug: Entecavir
Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
Other Names:
|
| Active Comparator: Entecavir 1.0 |
Drug: Entecavir
Tablets, Oral, 1.0 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started
Other Names:
|
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
- ALT ≤ 15 x upper limit of normal
- Compensated liver disease
Exclusion Criteria:
- Coinfection with HIV, HCV, or HDV
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00975091 History of Changes |
| Other Study ID Numbers: | AI463-050 |
| Study First Received: | September 8, 2009 |
| Last Updated: | January 29, 2010 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Entecavir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013