CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study - Full Text View

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00645736

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:	Cohort, Cross-Sectional
Official Title:	Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	800
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2008
Estimated 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 Pty Ltd ( Howard Wraight, Medical Director )
Study ID Numbers:	GS-AU-103-0185
Study First Received:	March 25, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00645736 History of Changes
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Gilead Sciences:

Chronic Hepatitis B

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis B, Chronic
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis B, Chronic
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009