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Clinical Trials/NCT00986778
NCT00986778
Withdrawn
Phase 4

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

Bristol-Myers Squibb0 sitesDecember 2009
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ConditionsHepatitis B, Chronic
InterventionsLamivudineAdefovirEntecavir
DrugsLamivudineEntecavirAdefovir

Overview

Phase
Phase 4
Intervention
Lamivudine
Conditions
Hepatitis B, Chronic
Sponsor
Bristol-Myers Squibb
Primary Endpoint
The proportion of patients with HBV DNA < 50 IU/mL at W48
Status
Withdrawn
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

Arms & Interventions

Lamivudine plus Adefovir

Intervention: Lamivudine

Lamivudine plus Adefovir

Intervention: Adefovir

Entecavir

Intervention: Entecavir

Entecavir plus Adefovir

Intervention: Entecavir

Entecavir plus Adefovir

Intervention: Adefovir

Outcomes

Primary Outcomes

The proportion of patients with HBV DNA < 50 IU/mL at W48

Time Frame: Week 48

Secondary Outcomes

  • Mean reduction of HBV DNA at W 48 & 96(Week 48 and 96)
  • The proportion of subjects with ALT normalization at W 48 & 96(Week 48 & Week 96)
  • The proportion of patient with HBV DNA < 50 IU/mL at W 96(Week 96)
  • The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96(Week 48 & 96)
  • Safety(Week 48 and Week 96)
  • Resistance(Week 48 & Week 96)

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