A Phase II Dose Response Study in Japan in Chronic Hepatitis B
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01022801
First received: November 30, 2009
Last updated: January 29, 2010
Last verified: November 2009
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Purpose
To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Entecavir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II Study in Japan of the Safety and Antiviral Activity of Entecavir (BMS-200475) vs Lamivudine in Adults With Chronic Hepatitis B Infection |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL) [ Time Frame: at Week 22 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine [ Time Frame: Through Week 24 (end of dosing) plus 5 days ] [ Designated as safety issue: Yes ]
- Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine [ Time Frame: Through Week 24 (end of dosing) plus 5 days ] [ Designated as safety issue: Yes ]
- HBV DNA as measured by PCR (log10 copies/mL) at Week 22 [to demonstrate non-inferiority of at least one dose of entecavir as compared with lamivudine] [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
- Proportion of subjects in each treatment group who achieve HBV DNA reduced by ≥2 log10 and/or below the limit of quantification (LOQ) (<400 copies/mL) as measured by PCR assay [ Time Frame: Week 12, Week 22 ] [ Designated as safety issue: No ]
- Proportion of subjects in each treatment group who achieve HBV DNA below the limit of detection (0.7 MEq/mL) of the Quantiplex branched DNA hybridization assay (Quantiplex assay) [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
- Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN) [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
- Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline [ Time Frame: Baseline, Week 22 ] [ Designated as safety issue: No ]
- Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
- Proportion of HBeAg-positive subjects at baseline who achieve responder status (defined as: HBV DNA <0.7 MEq/mL by the Quantiplex assay; loss of HBeAg and normal serum ALT) [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
- Proportion of HBeAg-negative subjects at baseline who achieve responder status (defined as HBV DNA <0.7 MEq/mL by the Quantiplex assay and normal serum ALT) [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
- Incidence of genotypic resistance of HBV isolates in subjects who have a ε 1 log10 increase in HBV DNA as measured by PCR assay after achieving the lowest value while on study drug [ Time Frame: Through Week 24 ] [ Designated as safety issue: No ]
- Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2003 |
| Study Completion Date: | March 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Entecavir (0.01 mg) |
Drug: Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Other Names:
|
| Experimental: Entecavir (0.1 mg) |
Drug: Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Other Names:
|
| Experimental: Entecavir (0.5 mg) |
Drug: Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Positive for HBsAg OR, negative for IgM core antibody and confirmation of chronic hepatitis B on liver biopsy,
- Positive for HBeAg OR negative for HBeAg with positive HBeAb,
- Documented HBV Viremia on 2 or more occasions: Viremia on sample drawn AND HBV DNA of ≥ 40 MEq/mL by Quantiplex assay at the screening visit
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01022801 History of Changes |
| Other Study ID Numbers: | AI463-047 |
| Study First Received: | November 30, 2009 |
| Last Updated: | January 29, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
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 June 17, 2013