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Entecavir Plus Adefovir in Lamivudine-Resistant Patients

This study has been withdrawn prior to enrollment.
(Business Objectives Changed)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00986778
First received: September 29, 2009
Last updated: December 10, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Hepatitis B, Chronic
 Drug: Lamivudine
Drug: Entecavir
Drug: Adefovir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The proportion of patients with HBV DNA < 50 IU/mL at W48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patient with HBV DNA < 50 IU/mL at W 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Mean reduction of HBV DNA at W 48 & 96 [ Time Frame: Week 48 and 96 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at W 48 & 96 [ Time Frame: Week 48 & Week 96 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96 [ Time Frame: Week 48 & 96 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Week 48 and Week 96 ] [ Designated as safety issue: Yes ]
  • Resistance [ Time Frame: Week 48 & Week 96 ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: December 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986778

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

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

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00986778     History of Changes
Other Study ID Numbers: AI463-195
Study First Received: September 29, 2009
Last Updated: December 10, 2009
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013