CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00645736
First received: March 25, 2008
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.


Condition Intervention
Chronic Hepatitis B
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Descriptive statistics for clinical and viral characteristics of the study population [ Time Frame: Single timepoint (blood draw) ] [ Designated as safety issue: No ]

Enrollment: 788
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Single cohort
Other: No intervention
No intervention

Detailed Description:

This is a naturalistic cross-sectional study of chronic hepatitis B subjects receiving nucleoside or nucleotide antihepadnaviral therapy.

It is anticipated approximately 800 subjects will be recruited at 20 Australian sites. Data will be collected on the study subjects and analyses performed to describe factors contributing to the emergence of viral mutations in Australian patients with chronic hepatitis B.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with a diagnosis of chronic hepatitis B who have been prescribed antihepadnaviral therapy for at least 6 months.

Criteria

Inclusion Criteria:

  • Aged 18 years and over
  • Provided informed consent
  • Diagnosis of chronic hepatitis B (HBsAg documented for at least 6 months)
  • Currently prescribed antihepadnaviral therapy (including, but not limited to: lamivudine, adefovir, entecavir, tenofovir or telbivudine) for chronic hepatitis B management
  • Been taking current antihepadnaviral therapy for at least 6 months prior to recruitment
  • Negative tests for HIV Ab, Hepatitis C Ab and Hepatitis D Ab within the previous 2 years

Exclusion Criteria:

  • Known or suspected co-infection with HIV, Hepatitis C or Hepatitis D
  • Concomitant immunosuppression / immunomodulatory therapies
  • Diagnosis of hepatocellular carcinoma where anticipated life expectancy is less than 6 months
  • Current participation in an interventional, blinded, pharmaceutical industry-sponsored clinical trial
  • Current Child Pugh class C classification (current Child Pugh score > 9)
  • Other known or suspected cause of chronic liver disease
  • Any other reason that, in the investigator's opinion, participation in the study would not be in the participant's best interest.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645736

Locations
Australia, Victoria
Gilead Sciences Pty Ltd
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Howard Wraight Gilead Sciences Pty Ltd
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00645736     History of Changes
Other Study ID Numbers: GS-AU-103-0185
Study First Received: March 25, 2008
Last Updated: November 21, 2011
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Gilead Sciences:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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

ClinicalTrials.gov processed this record on April 17, 2014