Chronic Hepatitis BCHARMNCT00645736
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study
An observational study of Chronic Hepatitis B, run by Gilead Sciences at 1 site in Australia.
Trial summary
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 788 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2008to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a diagnosis of chronic hepatitis B who have been prescribed antihepadnaviral therapy for at least 6 months.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- No intervention
- Keywords
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Single cohort Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistics for clinical and viral characteristics of the study population
Measured: Single timepoint (blood draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Wraight, Study director, Gilead Sciences Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645736
- Sponsor's protocol ID
- GS-AU-103-0185
- Acronym
- CHARM
- Status last verified
- Nov 2011
- First submitted
- 25 Mar 2008
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Acquired Viral Mutations in Chronic Hepatitis B Patients on Antihepadnaviral Therapy
- ClinicalTrials.gov ID
- NCT00645736
- Acronym / sponsor ID
- CHARM / GS-AU-103-0185
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 788 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has the aim of describing viral mutation profiles in patients diagnosed with chronic hepatitis B receiving antihepadnaviral therapy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No interventionSingle cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diagnosis of chronic hepatitis B who have been prescribed antihepadnaviral therapy for at least 6 months.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | 1 |
Primary outcome
Descriptive statistics for clinical and viral characteristics of the study population
Time frame: Single timepoint (blood draw)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Wraight study director
Gilead Sciences Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Gilead Sciences at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive statistics for clinical and viral characteristics of the study population (time frame: Single timepoint (blood draw)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.