Liver DysfunctionPhase 2NCT00117689
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
A Phase 2 study testing Thymoglobulin, Corticosteroid and Tacrolimus in people with Liver Dysfunction and Rejection, Transplant, run by Genzyme, a Sanofi Company at 16 sites in 2 countries.
Trial summary
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
- What is being tested?
- Thymoglobulin, Corticosteroid and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Apr 2005to Dec 2007
- Phase
- Phase 2
- 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
Who may be able to join
- Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation
- Serum creatinine > 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation
- Ages greater than or equal to 18 years
- If female, must not be lactating; must have a negative serum beta-human chorionic gonadotropin (HCG) test within 7 days prior to Study Day 0 (Day of Transplant); and must agree to practice an acceptable and reliable form of contraception during the study
- Signed informed consent
Who cannot join
- Living donor or multiple organ transplants
- Prior solid organ or bone marrow transplant recipient
- Fulminant hepatic failure
- Status 1 transplants
- ABO incompatible transplants
- Transplants utilizing livers from non heart-beating donors
Show all 17Show fewer
- Liver transplant candidates with > 6 weeks of analysis
- Donor with positive serology for hepatitis B surface antigen (HBsAg)
- Evidence of human immunodeficiency virus (HIV)
- Autoimmune hepatitis
- History of chronic steroid or immunosuppressant use in the 90 days prior to transplant, except for inhaled corticosteroids to treat asthma
- Recipient of investigational therapy within 90 days prior to transplant procedure
- Known contraindication to administration of rabbit anti-thymocyte globulin
- Acute viral illness
- History of malignancy within 5 years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence, and/or hepatocellular carcinoma
- Illness other than primary liver disease (e.g. severe ischemic heart disease, left ventricular dysfunction, or pulmonary disease), which, in the opinion of the investigator, may significantly increase the risk of the transplantation procedure
- Current drug and alcohol abuse that, in the opinion of the investigator, puts subjects at risk for poor compliance (no drug test required)
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Baylor University Medical Center
Dallas, Texas, 75246
University of Colorado Hospital and Health Sciences Center
Denver, Colorado, 80262
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
USC University Hospital
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33136
Fairview University Medical Center
Minneapolis, Minnesota, 55455
Mount Sinai Medical Center
New York, New York, 10029
University of Nebraska
Omaha, Nebraska, 68198
VCU Medical Center
Richmond, Virginia, 23298
University of Texas Health Science Center at San Antonio, University Hospital
San Antonio, Texas, 78229
University of California, San Fransisco Hospital
San Francisco, California, 94143
Washington University Medical Center
St Louis, Missouri, 63110
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Toronto University Hospital - UHN
Toronto, Ontario, M5G 2N2
About this study
Official title: A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.
- Being tested
- Thymoglobulin, Corticosteroid, Tacrolimus, Mycophenolate Mofetil
- Keywords
- Anti-T cell antibodies, Primary Liver Transplantation and Renal Dysfunction, Liver Transplant Rejection, Induction Therapy with reduction of Calcineurin inhibitors, Primary Liver Transplantation, Primary Transplant Rejection, Transplantation, Liver, Rejection, Transplant
- Medical subject headings
- Liver Diseases, Rejection, Psychology, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinBiological
Also called [Anti-thymocyte Globulin (rabbit)]
Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
CorticosteroidDrug
For a minimum of 3 months
TacrolimusDrug
Between Day 3 the last dose of Thymoglobulin
for at least 1 month posttransplant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard (tacrolimus based standard therapy without induction) Receives: Biological: Thymoglobulin; Drug: Tacrolimus; Drug: Mycophenolate Mofetil |
| 2 Standard of Care | Active comparator | Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy Receives: Drug: Corticosteroid; Drug: Tacrolimus; Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from biopsy-proven acute rejection (including humoral rejection)
Measured: 6 months
Secondary outcomes (2)
Explore the impact of Thymoglobulin on kidney function after transplant
Measured: 6 months
Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DysfunctionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117689
- Sponsor's protocol ID
- Thymo102700103
- Status last verified
- Mar 2015
- First submitted
- 30 Jun 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT00117689
- Acronym / sponsor ID
- Thymo102700103
- Keywords
- Anti-T cell antibodies, Primary Liver Transplantation and Renal Dysfunction, Liver Transplant Rejection, Induction Therapy with reduction of Calcineurin inhibitors, Primary Liver Transplantation, Primary Transplant Rejection, Transplantation, Liver, Rejection, Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Jul 2005 (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.
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Thymoglobulin, Drug: Tacrolimus, Drug: Mycophenolate MofetilStandard (tacrolimus based standard therapy without induction) |
| 2 Standard of Care | Active comparator | Drug: Corticosteroid, Drug: Tacrolimus, Drug: Mycophenolate MofetilThymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation
- Serum creatinine > 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation
- Ages greater than or equal to 18 years
- If female, must not be lactating; must have a negative serum beta-human chorionic gonadotropin (HCG) test within 7 days prior to Study Day 0 (Day of Transplant); and must agree to practice an acceptable and reliable form of contraception during the study
- Signed informed consent
Key exclusion criteria (17 listed)
- Living donor or multiple organ transplants
- Prior solid organ or bone marrow transplant recipient
- Fulminant hepatic failure
- Status 1 transplants
- ABO incompatible transplants
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 |
|---|---|---|
| ThymoglobulinAlso: [Anti-thymocyte Globulin (rabbit)]Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy | Biological | 1 |
| CorticosteroidFor a minimum of 3 months | Drug | 2 Standard of Care |
| TacrolimusBetween Day 3 the last dose of Thymoglobulin | Drug | 1, 2 Standard of Care |
| Mycophenolate Mofetilfor at least 1 month posttransplant | Drug | 1, 2 Standard of Care |
Primary outcome
Freedom from biopsy-proven acute rejection (including humoral rejection)
Time frame: 6 months
2 secondary outcomes
Explore the impact of Thymoglobulin on kidney function after transplant
Time frame: 6 months
Explore the impact of Thymoglobulin on the prevention of liver transplant rejection, transplanted liver loss, death, and safety of Thymoglobulin after transplant.
Time frame: 12 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 18 Mar 2015.
- US FDA Approved Full Prescribing Information for Thymoglobulin®Link provided by the sponsor.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymoglobulin, Corticosteroid and Tacrolimus in people with Liver Dysfunction and Rejection, Transplant, run by Genzyme, a Sanofi Company at 16 sites in 2 countries.
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 17 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Freedom from biopsy-proven acute rejection (including humoral rejection) (time frame: 6 months). 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 18 Mar 2015.