Chronic Hepatitis CPhase 1NCT00286871
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen
A Phase 1 study testing Neoral and Tacrolimus in people with Chronic Hepatitis C and Organ Transplantation, run by Duke University at 1 site in United States.
Trial summary
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C, Organ Transplantation, Immunosuppression
- What is being tested?
- Neoral and Tacrolimus
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients who have received liver transplant
Who cannot join
- pregnant women
- nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Steroid Avoidance in Hep C OLT
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
Read the detailed description
Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation. Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease. Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence. The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established. Previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively.
- Being tested
- Neoral, Tacrolimus
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoralDrug
TacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf
Secondary outcomes (1)
compare the effectiveness of Neoral with Prograf as primary immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- Devai Desai, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286871
- Sponsor's protocol ID
- 6538
- Other IDs
- 6538-04-11R0
- Status last verified
- Feb 2006
- First submitted
- 2 Feb 2006
- Last updated
- 22 Sep 2014
- Results posted
- No
Publications
Gane EJ, Portmann BC, Naoumov NV, Smith HM, Underhill JA, Donaldson PT, Maertens G, Williams R. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med. 1996 Mar 28;334(13):815-20. doi: 10.1056/NEJM199603283341302.
PubMed 8596547Berenguer M, Prieto M, Palau A, Rayon JM, Carrasco D, Juan FS, Lopez-Labrador FX, Moreno R, Mir J, Berenguer J. Severe recurrent hepatitis C after liver retransplantation for hepatitis C virus-related graft cirrhosis. Liver Transpl. 2003 Mar;9(3):228-35. doi: 10.1053/jlts.2003.50029.
PubMed 12619018McCaughan GW, Zekry A. Pathogenesis of hepatitis C virus recurrence in the liver allograft. Liver Transpl. 2002 Oct;8(10 Suppl 1):S7-S13. doi: 10.1053/jlts.2002.35856.
PubMed 12362292Zervos XA, Weppler D, Fragulidis GP, Torres MB, Nery JR, Khan MF, Pinna AD, Kato T, Miller J, Reddy KR, Tzakis AG. Comparison of tacrolimus with neoral as primary immunosuppression in hepatitis C patients after liver transplantation. Transplant Proc. 1998 Jun;30(4):1405-6. doi: 10.1016/s0041-1345(98)00291-7. No abstract available.
PubMed 9636568Eason JD, Loss GE, Blazek J, Nair S, Mason AL. Steroid-free liver transplantation using rabbit antithymocyte globulin induction: results of a prospective randomized trial. Liver Transpl. 2001 Aug;7(8):693-7. doi: 10.1053/jlts.2001.26353.
PubMed 11510013Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981 Sep-Oct;1(5):431-5. doi: 10.1002/hep.1840010511.
PubMed 7308988
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Avoidance in Hep C OLT
- ClinicalTrials.gov ID
- NCT00286871
- Acronym / sponsor ID
- 6538
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2006
- Study completion
- Feb 2009
- First posted
- 6 Feb 2006 (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.
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
Detailed description
Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation. Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease. Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence. The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established. Previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients who have received liver transplant
Key exclusion criteria (2 listed)
- pregnant women
- nursing women
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 |
|---|---|---|
| Neoral | Drug | – |
| Tacrolimus | Drug | – |
Primary outcome
compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf
1 secondary outcome
compare the effectiveness of Neoral with Prograf as primary immunotherapy
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 Sep 2014.
- Background: PubMed 8596547Gane EJ, Portmann BC, Naoumov NV, Smith HM, Underhill JA, Donaldson PT, Maertens G, Williams R. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med. 1996 Mar 28;334(13):815-20. doi: 10.1056/NEJM199603283341302.
- Background: PubMed 12619018Berenguer M, Prieto M, Palau A, Rayon JM, Carrasco D, Juan FS, Lopez-Labrador FX, Moreno R, Mir J, Berenguer J. Severe recurrent hepatitis C after liver retransplantation for hepatitis C virus-related graft cirrhosis. Liver Transpl. 2003 Mar;9(3):228-35. doi: 10.1053/jlts.2003.50029.
- Background: PubMed 12362292McCaughan GW, Zekry A. Pathogenesis of hepatitis C virus recurrence in the liver allograft. Liver Transpl. 2002 Oct;8(10 Suppl 1):S7-S13. doi: 10.1053/jlts.2002.35856.
- Background: PubMed 9636568Zervos XA, Weppler D, Fragulidis GP, Torres MB, Nery JR, Khan MF, Pinna AD, Kato T, Miller J, Reddy KR, Tzakis AG. Comparison of tacrolimus with neoral as primary immunosuppression in hepatitis C patients after liver transplantation. Transplant Proc. 1998 Jun;30(4):1405-6. doi: 10.1016/s0041-1345(98)00291-7. No abstract available.
- Background: PubMed 11510013Eason JD, Loss GE, Blazek J, Nair S, Mason AL. Steroid-free liver transplantation using rabbit antithymocyte globulin induction: results of a prospective randomized trial. Liver Transpl. 2001 Aug;7(8):693-7. doi: 10.1053/jlts.2001.26353.
- Background: PubMed 7308988Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981 Sep-Oct;1(5):431-5. doi: 10.1002/hep.1840010511.
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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.
Devai Desai, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neoral and Tacrolimus in people with Chronic Hepatitis C and Organ Transplantation, run by Duke University 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 1 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 22 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf. 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 NCT00286871, which also lists 6 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 22 Sep 2014.