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Trial record 95 of 131 for:    "Hepatitis" | "Lamivudine"

A Phase II Dose Response Study in Japan in Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT01022801
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Entecavir Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
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:
  • Baraclude
  • BMS-200475

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:
  • Baraclude
  • BMS-200475

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:
  • Baraclude
  • BMS-200475




Primary Outcome Measures :
  1. Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL) [ Time Frame: at Week 22 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine [ Time Frame: Through Week 24 (end of dosing) plus 5 days ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN) [ Time Frame: Week 22 ]
  7. 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 ]
  8. Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline [ Time Frame: Week 22 ]
  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response [ Time Frame: Week 22 ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022801


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01022801     History of Changes
Other Study ID Numbers: AI463-047
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: November 2009
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents