Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Hepatitis B, Chronic Clinical Trial

Official title:

A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00986778
• Other study ID #: AI463-195
• Status: Withdrawn
• Phase: Phase 4
• First received: September 29, 2009
• Last updated: August 31, 2015
• Start date: December 2009
• Est. completion date: June 2014

Study information

• Verified date: December 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I

• Naïve to nucleoside/nucleotide analogues except for LVD

• HBV DNA > 17,200 IU/mL

• Compensated liver function

• Serum ALT <10 × ULN

Exclusion Criteria:

• Women who are pregnant or breastfeeding

• Evidence of decompensated cirrhosis

• Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Lamivudine
Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
• Entecavir
Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
• Adefovir
Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with HBV DNA < 50 IU/mL at W48		Week 48	No
Secondary	The proportion of patient with HBV DNA < 50 IU/mL at W 96		Week 96	No
Secondary	Mean reduction of HBV DNA at W 48 & 96		Week 48 and 96	No
Secondary	The proportion of subjects with ALT normalization at W 48 & 96		Week 48 & Week 96	No
Secondary	The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96		Week 48 & 96	No
Secondary	Safety		Week 48 and Week 96	Yes
Secondary	Resistance		Week 48 & Week 96	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