Entecavir Plus Adefovir in Lamivudine-Resistant Patients

August 31, 2015 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Entecavir
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
Other Names:
  • Baraclude
Active Comparator: Lamivudine plus Adefovir
Drug: Lamivudine
Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
Other Names:
  • Heptotin
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
Other Names:
  • Hepsera
Experimental: Entecavir plus Adefovir
Drug: Adefovir
Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
Other Names:
  • Hepsera
Drug: Entecavir
Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
Other Names:
  • Baraclude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with HBV DNA < 50 IU/mL at W48
Time Frame: Week 48
Week 48

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI463-195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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