Hepatitis CNCT01429155
Outcomes in Hepatitis C After Living Donor Liver Transplantation in Association With Interleukin 28 B
An observational study of Hepatitis C, run by Henry Ford Health System at 1 site in United States.
Trial summary
Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a national organ shortage, living donor liver transplantation has became a viable option for patients with end stage liver disease who are not severely ill. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Interleukin 28B genotype
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2013
- 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: Chronic hepatitis C patients that required a living donor liver transplant will be identified from the liver tranplant registry. Living liver donors will be indentified from the liver tranplant registry.
Who may be able to join
- Patients who received a living donor liver transplant for chronic hepatitis C who are 18 year or older
- Patients who donated part of their liver to patients suffering from chronic hepatitis C. Donors must be 18 years or older
Who cannot join
- Patients who are not willing to sign the consent
- Inability to obtain liver specimen (recipients)
- Inability to obtain blood sample (donors)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Transplant Course of Hepatitis C Patients After Living Donor Liver Transplant in Association With Interleukin 28 B
Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a national organ shortage, living donor liver transplantation has became a viable option for patients with end stage liver disease who are not severely ill. Recently particular polymorphisms of IL-28B gene were reported to correlate with histological recurrence and antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar results have not been described yet in living donor liver transplant patients.
There is data suggesting slightly inferior outcomes in living donor liver transplants when done for hepatitis C. The investigators postulate that such inferior outcomes may be related to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive similarly unfavorable polymorphism livers from their relatives).
- Conditions
- Hepatitis C
- Being tested
- Interleukin 28B genotype
- Keywords
- End stage liver disease, Living donor liver transplantation, Hepatitis C, Interleukin 28B
- Medical subject headings
- Hepatitis C, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin 28B genotypeGenetic
Interleukin 28B genotype will be obtained from a tissue block of the liver explant (liver transplanted patients) Interleukin 28B genotype will be obtained from a blood sample drawn (liver donors)
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipeints | Patients suffering from chronic hepatitis C that required a living donor liver transplant. Receives: Genetic: Interleukin 28B genotype | |
| Liver Donors | Patients who donated part of their liver to a patient suffering from chronic hepatitis C Receives: Genetic: Interleukin 28B genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response after living donor liver transplant
Determine if sustained virological response is achieved after liver transplantation for hepatitis C with antiviral therapy (rivabirin and pegelated interferon) based on patient IL28B genotype
Measured: 12-24 months
Secondary outcomes (1)
Liver retransplantation
Determine the need of liver retransplantion based on the IL 28B genotype
Measured: 1-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humberto C. Gonzalez, Henry Ford Health System
- Investigators
- Humberto C Gonzalez, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429155
- Sponsor's protocol ID
- 6975
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2011
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Charlton MR, Thompson A, Veldt BJ, Watt K, Tillmann H, Poterucha JJ, Heimbach JK, Goldstein D, McHutchison J. Interleukin-28B polymorphisms are associated with histological recurrence and treatment response following liver transplantation in patients with hepatitis C virus infection. Hepatology. 2011 Jan;53(1):317-24. doi: 10.1002/hep.24074.
PubMed 21254179Eurich D, Boas-Knoop S, Ruehl M, Schulz M, Carrillo ED, Berg T, Neuhaus R, Neuhaus P, Neumann UP, Bahra M. Relationship between the interleukin-28b gene polymorphism and the histological severity of hepatitis C virus-induced graft inflammation and the response to antiviral therapy after liver transplantation. Liver Transpl. 2011 Mar;17(3):289-98. doi: 10.1002/lt.22235.
PubMed 21384511
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Transplant Course of Hepatitis C Patients After Living Donor Liver Transplant in Association With Interleukin 28 B
- ClinicalTrials.gov ID
- NCT01429155
- Acronym / sponsor ID
- 6975
- Conditions
- Hepatitis C
- Keywords
- End stage liver disease, Living donor liver transplantation, Hepatitis C, Interleukin 28B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Sep 2011 (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.
Hepatitis C is the leading cause of liver transplants in the USA. Given that there is a national organ shortage, living donor liver transplantation has became a viable option for patients with end stage liver disease who are not severely ill. Recently particular polymorphisms of IL-28B gene were reported to correlate with histological recurrence and antiviral treatment response after orthotopic liver transplantation for hepatitis C. Similar results have not been described yet in living donor liver transplant patients.
There is data suggesting slightly inferior outcomes in living donor liver transplants when done for hepatitis C. The investigators postulate that such inferior outcomes may be related to IL28 polymorphism concordance (i.e., unfavorable recipient polymorphism patients receive similarly unfavorable polymorphism livers from their relatives).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipeints | – | Genetic: Interleukin 28B genotypePatients suffering from chronic hepatitis C that required a living donor liver transplant. |
| Liver Donors | – | Genetic: Interleukin 28B genotypePatients who donated part of their liver to a patient suffering from chronic hepatitis C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis C patients that required a living donor liver transplant will be identified from the liver tranplant registry. Living liver donors will be indentified from the liver tranplant registry.
Key inclusion criteria (2 listed)
- Patients who received a living donor liver transplant for chronic hepatitis C who are 18 year or older
- Patients who donated part of their liver to patients suffering from chronic hepatitis C. Donors must be 18 years or older
Key exclusion criteria (3 listed)
- Patients who are not willing to sign the consent
- Inability to obtain liver specimen (recipients)
- Inability to obtain blood sample (donors)
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 |
|---|---|---|
| Interleukin 28B genotypeInterleukin 28B genotype will be obtained from a tissue block of the liver explant (liver transplanted patients) Interleukin 28B genotype will be obtained from a blood sample drawn (liver donors) | Genetic | Liver Donors, Liver transplant recipeints |
Primary outcome
Sustained virological response after living donor liver transplant
Time frame: 12-24 months
Determine if sustained virological response is achieved after liver transplantation for hepatitis C with antiviral therapy (rivabirin and pegelated interferon) based on patient IL28B genotype
1 secondary outcome
Liver retransplantation
Time frame: 1-24 months
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 17 Sep 2014.
- Background: PubMed 21254179Charlton MR, Thompson A, Veldt BJ, Watt K, Tillmann H, Poterucha JJ, Heimbach JK, Goldstein D, McHutchison J. Interleukin-28B polymorphisms are associated with histological recurrence and treatment response following liver transplantation in patients with hepatitis C virus infection. Hepatology. 2011 Jan;53(1):317-24. doi: 10.1002/hep.24074.
- Background: PubMed 21384511Eurich D, Boas-Knoop S, Ruehl M, Schulz M, Carrillo ED, Berg T, Neuhaus R, Neuhaus P, Neumann UP, Bahra M. Relationship between the interleukin-28b gene polymorphism and the histological severity of hepatitis C virus-induced graft inflammation and the response to antiviral therapy after liver transplantation. Liver Transpl. 2011 Mar;17(3):289-98. doi: 10.1002/lt.22235.
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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.
Humberto C Gonzalez, MD principal investigator
Henry Ford Hospital
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, run by Henry Ford Health System at 1 site in United States.
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 3 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 17 Sep 2014. 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 United States. 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?
Sustained virological response after living donor liver transplant (time frame: 12-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01429155, which also lists 2 linked publications.
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 17 Sep 2014.