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Clinical Trials/EUCTR2007-001269-14-DE
EUCTR2007-001269-14-DE
Active, not recruiting
Not Applicable

A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovirversus Adefovir Added to Continuing Lamivudine in Adults with Lamivudine ResistantChronic Hepatitis B Virus Infection. Revised Protocol 02, incorporating protocol amendment 01 (v1.0, Date 03-Jan-2008), protocol amendment 02 (v1.0, Date 31-Jul-2008) and Administrative Letter 01 (Date 06-Jun-2008).

Bristol-Myers Squibb International Corporation0 sites105 target enrollmentApril 15, 2008
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ConditionsHEPATITIS B VIRUSMedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
DrugsVireadBaracludeHepseraZeffix

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HEPATITIS B VIRUS
Sponsor
Bristol-Myers Squibb International Corporation
Enrollment
105
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 15, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\) Signed Written Informed Consent
  • •2\) Subjects with chronic HBV infection (detectable HBsAg at screening and for at least
  • •24 weeks prior to screening, or detectable HBsAg for \< 24 weeks and negative for
  • •IgM core antibody); subjects may be either HBeAg\-positive or HBeAg\-negative;
  • •3\) Subjects must have a history of previous lamivudine treatment, must have LVD
  • •resistance substitutions at reverse transcriptase rtM204I/V ± rtL180M, documented
  • •by INNO\-Lipa HBV\-DR assay, and must be receiving lamivudine at the screening
  • •4\) Subjects must have compensated liver function and must meet ALL of the following
  • •International Normalization Ratio (INR) \= 1\.5
  • •Serum albumin \= 3 g/dL (\= 30 g/L)

Exclusion Criteria

  • •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 6 weeks after the last dose of
  • •investigational product.
  • •2\) Evidence of decompensated cirrhosis including but not limited to: variceal bleeding;
  • •hepatic encephalopathy; or ascites requiring management with diuretics or
  • •paracentesis;
  • •3\) Coinfection with HIV, hepatitis C virus (\[HCV]; coinfection is defined as HCV
  • •Ab\-positive with detectable HCV ribonucleic acid \[RNA] by PCR), or hepatitis D
  • •virus (HDV).
  • •4\) Recent history of pancreatitis (within 24 weeks prior to the first dose of study

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
A Phase III Study of the Safety and Efficacy or Entecavir in Pediatric Patients with Chronic HBV-InfectioCHRONIC HEPATITIS B VIRUS,PEDIATRICMedDRA version: 14.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2009-016357-17-BEBristol-Myers Squibb International Corporation180
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Comparative study in childrens with chronic Hepatitis B virus infection who are HBeAg positive.
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A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) versus Placebo in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-PositiveCHRONIC HEPATITIS B VIRUS,PEDIATRICMedDRA version: 12.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
EUCTR2009-016357-17-GRBristol-Myers Squibb International Corporation257
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A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir versus Adefovir Added to Continuing Lamivudine in Adults with Lamivudine Resistant Chronic Hepatitis B Virus Infection. - NDHepatitis B VirusMedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
EUCTR2007-001269-14-ITBRISTOL-M.SQUIBB84
Active, not recruiting
Phase 1
A Phase III Study of the Safety and Efficacy or Entecavir in Pediatric Patients with Chronic HBV-InfectioCHRONIC HEPATITIS B VIRUS,PEDIATRICMedDRA version: 14.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2009-016357-17-DEBristol-Myers Squibb International Corporation180