Acute Hepatitis CATAHC RecallNCT02000063
Australian Trial in Acute Hepatitis C Recall Study
An observational study of Acute Hepatitis C, run by Kirby Institute at 3 sites in Australia.
Trial summary
A single long-term follow up assessment of an established multi-centre, prospective longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes 4 to 8 years after previous treatment for recently acquired hepatitis C virus infection. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Hepatitis C
- How many people
- 50 participants
- Where
- 3 sitesAustralia
- Study dates
- Aug 2012to Mar 2014
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: An anticipated 60 participants will be recruited from 3 study sites: St Vincent's Hospital, Sydney; The Alfred Hospital, Melbourne; Royal Adelaide Hospital, Adelaide.
Who may be able to join
- Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study.
- Provision of written, informed consent.
Who cannot join
- In the opinion of the investigator that the patient is not able to provide informed consent.
- Inability or unwillingness to comply with study collection requirements.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Alfred Hospital
Melbourne, Victoria, 3005
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official title: Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.
A single long-term follow up assessment of an established multi-centre, prospective longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes 4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.
Read the detailed description
The study aims are:
- To evaluate the effect of successful prior treatment or spontaneous clearance of recently acquired HCV infection on long-term quality of life, social functioning, injecting behaviour, mental health and liver health.
- To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection.
- To determine predictors of HCV re-infection following recently acquired HCV infection treatment.
- To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia.
- To add to a tissue repository of serum and PBMCs from well-characterised patients treated for recently acquired HCV infection to allow future examination of the role of other variables that may potentially impact on the prognosis and outcomes of early HCV treatment.
- Conditions
- Acute Hepatitis C
- Keywords
- Hepatitis C, acute, early chronic
- Medical subject headings
- Hepatitis C, Bronchiolitis Obliterans Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term effects of HCV clearance
Health related quality of life (measured by SF-12) Social functioning (measured by OTI survey) Injecting behaviour Mental health (measured by DASS and MINI) Liver health (measured by FibroScan and biochemical markers)
Measured: 4 to 8 years from initial infection
Secondary outcomes (1)
Incidence of HCV re-infection
Rate of HCV RNA positivity in patients previously HCV RNA negative.
Measured: 4 to 8 years from initial infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hepatitis CStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, MBChB, MRCP (UK), FRACP, PhD, Principal investigator, University of New South Wales, Syndey Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000063
- Sponsor's protocol ID
- VHCRP1105
- Other IDs
- VHCRP1105
- Acronym
- ATAHC Recall
- Status last verified
- Sep 2014
- First submitted
- 12 Nov 2013
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes Following Treatment of Recently Acquired Hepatitis C Virus Infection.
- ClinicalTrials.gov ID
- NCT02000063
- Acronym / sponsor ID
- ATAHC Recall / VHCRP1105
- Conditions
- Acute Hepatitis C
- Keywords
- Hepatitis C, acute, early chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- The University of New South Wales
- Study start
- Aug 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Dec 2013 (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.
A single long-term follow up assessment of an established multi-centre, prospective longitudinal cohort study of patients for clinical, psychosocial, immunovirological outcomes 4 to 8 years after previous treatment for recently acquired hepatitis C virus infection.
Detailed description
The study aims are:
- To evaluate the effect of successful prior treatment or spontaneous clearance of recently acquired HCV infection on long-term quality of life, social functioning, injecting behaviour, mental health and liver health.
- To assess the incidence of HCV re-infection following prior treatment induced clearance or spontaneous clearance of recently acquired chronic HCV infection.
- To determine predictors of HCV re-infection following recently acquired HCV infection treatment.
- To determine frequency and predictors of new mixed and superinfections in ATAHC subjects with persistent viraemia.
- To add to a tissue repository of serum and PBMCs from well-characterised patients treated for recently acquired HCV infection to allow future examination of the role of other variables that may potentially impact on the prognosis and outcomes of early HCV treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An anticipated 60 participants will be recruited from 3 study sites: St Vincent's Hospital, Sydney; The Alfred Hospital, Melbourne; Royal Adelaide Hospital, Adelaide.
Key inclusion criteria (2 listed)
- Previous enrolment in the Australian Trial of Acute Hepatitis C Virus Infection (ATAHC) Study.
- Provision of written, informed consent.
Key exclusion criteria (2 listed)
- In the opinion of the investigator that the patient is not able to provide informed consent.
- Inability or unwillingness to comply with study collection requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term effects of HCV clearance
Time frame: 4 to 8 years from initial infection
Health related quality of life (measured by SF-12) Social functioning (measured by OTI survey) Injecting behaviour Mental health (measured by DASS and MINI) Liver health (measured by FibroScan and biochemical markers)
1 secondary outcome
Incidence of HCV re-infection
Time frame: 4 to 8 years from initial infection
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 1 Oct 2014.
- UNSW Kirby Institute for infection and immunity in society HomepageLink provided by the sponsor.
Related trials for Acute Hepatitis C
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Liver Transplant Recipients
Liver Transplant, Hepatitis C
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.
Gail Matthews, MBChB, MRCP (UK), FRACP, PhD principal investigator
University of New South Wales, Syndey Australia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hepatitis C, run by Kirby Institute at 3 sites 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 2 inclusion and 2 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Long-term effects of HCV clearance (time frame: 4 to 8 years from initial infection). 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 1 Oct 2014.