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Entecavir Plus Adefovir in Lamivudine-Resistant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00986778
Recruitment Status : Withdrawn (Business Objectives Changed)
First Posted : September 30, 2009
Last Update Posted : September 1, 2015
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Lamivudine Drug: Entecavir Drug: Adefovir Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Chinese Subjects
Study Start Date : December 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. The proportion of patients with HBV DNA < 50 IU/mL at W48 [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. The proportion of patient with HBV DNA < 50 IU/mL at W 96 [ Time Frame: Week 96 ]
  2. Mean reduction of HBV DNA at W 48 & 96 [ Time Frame: Week 48 and 96 ]
  3. The proportion of subjects with ALT normalization at W 48 & 96 [ Time Frame: Week 48 & Week 96 ]
  4. The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96 [ Time Frame: Week 48 & 96 ]
  5. Safety [ Time Frame: Week 48 and Week 96 ]
  6. Resistance [ Time Frame: Week 48 & Week 96 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

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): NCT00986778


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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00986778     History of Changes
Other Study ID Numbers: AI463-195
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: December 2009

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Lamivudine
Adefovir
Adefovir dipivoxil
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents