CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study

Chronic Hepatitis B Clinical Trial

— CHARM  

Official title:

Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645736
• Other study ID #: GS-AU-103-0185
• Status: Completed
• Phase: N/A
• First received: March 25, 2008
• Last updated: November 21, 2011
• Start date: February 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2011
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 788
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Australia	Gilead Sciences Pty Ltd	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive statistics for clinical and viral characteristics of the study population		Single timepoint (blood draw)	No