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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022801
• Other study ID #: AI463-047
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2009
• Last updated: January 29, 2010
• Start date: August 2003
• Est. completion date: March 2005

Study information

• Verified date: November 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir
Capsule, P.O., 0.01, 0.1 or 0.5 mg, once daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in HBV DNA levels as measured by by PCR (log10 copies/mL)		at Week 22	No
Secondary	Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine		Through Week 24 (end of dosing) plus 5 days	Yes
Secondary	Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine		Through Week 24 (end of dosing) plus 5 days	Yes
Secondary	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]		Week 22	No
Secondary	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		Week 12, Week 22	No
Secondary	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)		Week 22	No
Secondary	Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)		Week 22	No
Secondary	Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline		Baseline, Week 22	No
Secondary	Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline		Week 22	No
Secondary	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)		Week 22	No
Secondary	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)		Week 22	No
Secondary	Incidence of genotypic resistance of HBV isolates in subjects who have a e 1 log10 increase in HBV DNA as measured by PCR assay after achieving the lowest value while on study drug		Through Week 24	No
Secondary	Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response		Week 22	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form