Hepatitis C VirusNCT00710801
Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation
An observational study of Hepatitis C Virus, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV) infection than Tacrolimus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C Virus
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCV positive patients undergoing orthotopic liver transplantation
Who may be able to join
- About to undergo a primary liver transplant (including living donor, split liver) and are HCV positive.
- Willing and capable of giving written consent for study participation
- Expected to be capable of study participation for full 24 months post-transplantation.
- Allograft biopsies will be possible
- Expected use of calcineurin inhibitor (Neoral or Tacrolimus) as primary immunosuppression An immunosuppressive regimen consisting of a calcineurin inhibitor (Neoral or Tacrolimus) in combination with Simulect and MYCOPHENOLATE SODIUM
Who cannot join
- This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
- This is a liver transplant from a non-heart beating donor.
- This is an ABO incompatible transplant.
- Patients with serum creatinine level > 250 umol/L.
- The recipient is seropositive for human immunodeficiency virus (HIV) antibodies.
- Fulminant liver failure is the reason for transplant.
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- Patient is participating in other clinical trial involving exploratory drug
- There is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting Milan criteria for transplantation5.
- The patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
- Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
- A female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
- An unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label Study to Evaluate the Hepatitis C Virus (HCV) Burden in Patients Receiving Cyclosporine (Neoral or CSA) Versus Tacrolimus (Prograf) in de Novo Liver Recipients Receiving Mycophenolate Sodium (Myfortic): Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation
The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV) infection than Tacrolimus.
Read the detailed description
We will address the hypothesis that CSA has a superior antiviral effect against HCV than Tacrolimus by assessing serial HCV RNA levels in serum. We plan to address the hypothesis that CSA is more efficient in limiting viremia than Tacrolimus and that viremia is predictive of long-term clinical outcome of hepatic fibrosis that is known to impact on both graft and patient survival
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C Virus, HCV, Liver Transplant, Cyclosporine, Tacrolimus, Myfortic
- Medical subject headings
- Hepatitis C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Andrew L Mason, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710801
- Sponsor's protocol ID
- COLO400A2427
- Status last verified
- Sep 2011
- First submitted
- 2 Jul 2008
- Last updated
- 15 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label Study to Evaluate the Hepatitis C Virus (HCV) Burden in Patients Receiving Cyclosporine (Neoral or CSA) Versus Tacrolimus (Prograf) in de Novo Liver Recipients Receiving Mycophenolate Sodium (Myfortic): Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation
- ClinicalTrials.gov ID
- NCT00710801
- Acronym / sponsor ID
- COLO400A2427
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C Virus, HCV, Liver Transplant, Cyclosporine, Tacrolimus, Myfortic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2005
- First posted
- 4 Jul 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.
The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV) infection than Tacrolimus.
Detailed description
We will address the hypothesis that CSA has a superior antiviral effect against HCV than Tacrolimus by assessing serial HCV RNA levels in serum. We plan to address the hypothesis that CSA is more efficient in limiting viremia than Tacrolimus and that viremia is predictive of long-term clinical outcome of hepatic fibrosis that is known to impact on both graft and patient survival
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV positive patients undergoing orthotopic liver transplantation
Key inclusion criteria (5 listed)
- About to undergo a primary liver transplant (including living donor, split liver) and are HCV positive.
- Willing and capable of giving written consent for study participation
- Expected to be capable of study participation for full 24 months post-transplantation.
- Allograft biopsies will be possible
- Expected use of calcineurin inhibitor (Neoral or Tacrolimus) as primary immunosuppression An immunosuppressive regimen consisting of a calcineurin inhibitor (Neoral or Tacrolimus) in combination with Simulect and MYCOPHENOLATE SODIUM
Key exclusion criteria (12 listed)
- This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
- This is a liver transplant from a non-heart beating donor.
- This is an ABO incompatible transplant.
- Patients with serum creatinine level > 250 umol/L.
- The recipient is seropositive for human immunodeficiency virus (HIV) antibodies.
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
Not reported in the source record.
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 15 Sep 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.
Andrew L Mason, MD principal investigator
University of Alberta
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 Hepatitis C Virus, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 12 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 15 Sep 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 Canada. 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.
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 15 Sep 2011.