Hepatitis CPhase 3NCT00469131
Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
A Phase 3 study testing tacrolimus + steroid and tacrolimus + mycophenolate mofetil in people with Hepatitis C and Liver Cirrhosis, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatitis C, Liver Cirrhosis
- What is being tested?
- tacrolimus + steroid and tacrolimus + mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2003to Aug 2011
- Phase
- Phase 3
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of living donor liver transplantation for HCV-related cirrhosis
Who cannot join
- ABO blood type incompatible transplant case
- Renal dysfunction (serum creatinine >2.0 mg/dL)
- WBC < 1,000/mm3
- Hemoglobin < 8 g/dL
- Platelet <30,000 /mm3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.
- Conditions
- Hepatitis C, Liver Cirrhosis
- Being tested
- tacrolimus + steroid, tacrolimus + mycophenolate mofetil
- Keywords
- liver transplantation,, HCV recurrence,, immunosuppression
- Medical subject headings
- Hepatitis C, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus + steroidDrug
tacrolimus + mycophenolate mofetilDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 Drug: | Active comparator | tacrolimus + steroid Receives: Drug: tacrolimus + steroid |
| 2 Drug: | Active comparator | tacrolimus + mycophenolate mofetil Receives: Drug: tacrolimus + mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival time at the end of first year after living liver transplantation.
Measured: 1 year
Secondary outcomes (1)
HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startSep 2003
- Primary completionAug 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Kyoto University
- Investigators
- Shinji Uemoto, MD, PhD, Principal investigator, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469131
- Sponsor's protocol ID
- UHA-LD-03-01
- Status last verified
- Sep 2011
- First submitted
- 3 May 2007
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Takada Y, Kaido T, Asonuma K, Sakurai H, Kubo S, Kiuchi T, Inomata Y, Isaji S, Tsumura H, Teramukai S, Matsubara Y, Sakabayashi S, Uemoto S. Randomized, multicenter trial comparing tacrolimus plus mycophenolate mofetil to tacrolimus plus steroids in hepatitis C virus-positive recipients of living donor liver transplantation. Liver Transpl. 2013 Aug;19(8):896-906. doi: 10.1002/lt.23679.
PubMed 23696054
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
- ClinicalTrials.gov ID
- NCT00469131
- Acronym / sponsor ID
- UHA-LD-03-01
- Conditions
- Hepatitis C, Liver Cirrhosis
- Keywords
- liver transplantation,, HCV recurrence,, immunosuppression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Kyoto University
- Study start
- Sep 2003
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 May 2007 (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 aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Drug: | Active comparator | Drug: tacrolimus + steroidtacrolimus + steroid |
| 2 Drug: | Active comparator | Drug: tacrolimus + mycophenolate mofetiltacrolimus + mycophenolate mofetil |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recipient of living donor liver transplantation for HCV-related cirrhosis
Key exclusion criteria (5 listed)
- ABO blood type incompatible transplant case
- Renal dysfunction (serum creatinine >2.0 mg/dL)
- WBC < 1,000/mm3
- Hemoglobin < 8 g/dL
- Platelet <30,000 /mm3
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 |
|---|---|---|
| tacrolimus + steroid | Drug | 1 Drug: |
| tacrolimus + mycophenolate mofetil | Drug | 2 Drug: |
Primary outcome
Event-free survival time at the end of first year after living liver transplantation.
Time frame: 1 year
1 secondary outcome
HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection
Time frame: 1 year
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 14 Sep 2011.
- Derived from this study: PubMed 23696054Takada Y, Kaido T, Asonuma K, Sakurai H, Kubo S, Kiuchi T, Inomata Y, Isaji S, Tsumura H, Teramukai S, Matsubara Y, Sakabayashi S, Uemoto S. Randomized, multicenter trial comparing tacrolimus plus mycophenolate mofetil to tacrolimus plus steroids in hepatitis C virus-positive recipients of living donor liver transplantation. Liver Transpl. 2013 Aug;19(8):896-906. doi: 10.1002/lt.23679.
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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.
Shinji Uemoto, MD, PhD principal investigator
Kyoto University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus + steroid and tacrolimus + mycophenolate mofetil in people with Hepatitis C and Liver Cirrhosis, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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 5 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 14 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Event-free survival time at the end of first year after living liver transplantation. (time frame: 1 year). 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 NCT00469131, which also lists 1 linked publication.
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 14 Sep 2011.