End Stage Liver DiseasePhase 4NCT00163657
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
A Phase 4 study testing Daclizumub, Tacrolimus and Cyclosporine in people with End Stage Liver Disease and Hepatitis C, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver Disease, Hepatitis C
- What is being tested?
- Daclizumub, Tacrolimus and Cyclosporine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jan 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.
- Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C.
- Patient is > age 18.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a liver.
- Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor.
- Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver.
- Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C).
- Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant.
- Patient is intubated, on vasopressors, is ICU bound, or has experienced a significant blood loss (greater than 5 units) 72 hours prior to transplant procedure.
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- Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology.
- Patient is to receive antilymphocyte antibody induction therapy, such as ATGAM (lymphocyte immune globulin), OKT3 (muromonab-CD3), Simulect (basiliximab), or Thymoglobulin.
- Patient has a known hypersensitivity to Prograf (TAC), HCO-60, CellCept (MMF), Zenapax or corticosteroids.
- Patient is pregnant or lactating.
- Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
- Patient has participated in a trial involving a market drug within 30 days. However, patients who participated in any interferon or ribavirin trials are permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Regional Transplant Institute - Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among 3 Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For ESLD Caused By Chronic Hepatitis C
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
Read the detailed description
End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver.
Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved.
Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable.
This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.
- Conditions
- End Stage Liver Disease, Hepatitis C
- Being tested
- Daclizumub, Tacrolimus, Cyclosporine, MMF
- Keywords
- Hepatitis C Virus, Immunosuppressive Agents
- Medical subject headings
- End Stage Liver Disease, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumubDrug
Also called Zenapax
anti-rejection drug
TacrolimusDrug
Also called Prograf
anti rejection drug
CyclosporineDrug
Also called Neoral
anti rejection drug
MMFDrug
Also called mycophenolate mofetil
anti rejection drug
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus and cyclosporine | Active comparator | immunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine Receives: Drug: Daclizumub; Drug: Tacrolimus |
| MMF, tacrolimus and cyclosporine | Active comparator | immunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine Receives: Drug: Tacrolimus; Drug: Cyclosporine; Drug: MMF |
| daclizumub, MMFand tacrolimus | Active comparator | immunosuppressant treatment regimens Receives: Drug: Daclizumub; Drug: Tacrolimus; Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"
Measured: 12 months
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence
Measured: 12 month post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionApr 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Health Care System, Emory University, University of Southern California, Mayo Clinic - Scottsdale/Phoenix, Arizona, New York Presbyterian Hospital, Oregon Health and Science University, New York University, University of Cincinnati, University of Alabama at Birmingham, The University of Texas Health Science Center at San Antonio, University of Chicago, University of California, San Francisco, Mayo Clinic - Rochester, Minnesota, Medical University of South Carolina, University of Virginia, Lahey Clinic, University of Medicine and Dentistry of New Jersey, Northwestern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Goran Klintmalm, MD, Principal investigator, Baylor Univeristy Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163657
- Sponsor's protocol ID
- 02-01-L
- Other IDs
- ZEN159
- Status last verified
- Nov 2016
- First submitted
- 9 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No their is not a plan to make individual Participant data available
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Prospective Multicenter Study To Compare The Efficacy And Safety Among 3 Immunosuppressant Treatment Regimens In Patients Receiving A Liver Transplant For ESLD Caused By Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00163657
- Acronym / sponsor ID
- 02-01-L
- Conditions
- End Stage Liver Disease, Hepatitis C
- Keywords
- Hepatitis C Virus, Immunosuppressive Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Baylor Health Care System, Emory University, University of Southern California, Mayo Clinic - Scottsdale/Phoenix, Arizona, New York Presbyterian Hospital, Oregon Health and Science University, New York University, University of Cincinnati, University of Alabama at Birmingham, The University of Texas Health Science Center at San Antonio, University of Chicago, University of California, San Francisco, Mayo Clinic - Rochester, Minnesota, Medical University of South Carolina, University of Virginia, Lahey Clinic, University of Medicine and Dentistry of New Jersey, Northwestern Memorial Hospital
- Study start
- Jul 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 12 Jan 2017
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 compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
Detailed description
End-stage liver disease due to Hepatitis C virus (HCV) infection is the most common reason for liver transplantation in the United States. Patients who have HCV will always carry the virus in their body. If patients respond to treatment, the virus is no longer active. This means that although the virus is still present, it is not currently causing damage to their liver.
Because recurrence of HCV is virtually universal in HCV positive transplant recipients and is associated with long term, possibly lethal complications, the search for the most appropriate therapies must also include methods to prevent or minimize recurrence or disease progression, if the goal of improving long term outcomes for these patients is to be achieved.
Corticosteroids and high doses of immunosuppressive agents have been associated with increased rates of HCV recurrence. Finding a regimen that provides adequate immunosuppression to prevent early and late rejection episodes, and minimizes steroid usage as well as high doses of other immunosuppressive agents is highly desirable.
This study is being conducted to determine the most effective immunosuppressive regimen that will prevent allograft rejection, minimize adverse events and at the same time, prevent or reduce the incidence of HCV recurrence following liver transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tacrolimus and cyclosporine | Active comparator | Drug: Daclizumub, Drug: Tacrolimusimmunosuppressant treatment regimens the intervention is antirejection treatment with the above labeled drugs tacrolimus and cyclosporine |
| MMF, tacrolimus and cyclosporine | Active comparator | Drug: Tacrolimus, Drug: Cyclosporine, Drug: MMFimmunosuppressant treatment regimensthe intervention is antirejection treatment with the above labeled drugs MMF tacrolimus and cyclosporine |
| daclizumub, MMFand tacrolimus | Active comparator | Drug: Daclizumub, Drug: Tacrolimus, Drug: MMFimmunosuppressant treatment regimens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.
- Patient is a recipient of a primary whole/split, cadaveric/living donor liver transplant for end stage chronic Hepatitis C.
- Patient is > age 18.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.
Key exclusion criteria (12 listed)
- Patient has previously received or is receiving an organ transplant other than a liver.
- Patient has received a liver transplant from a Hepatitis B core antibody or a Hepatitis C antibody positive donor.
- Patient has received an ABO (blood group anti A, anti B antibodies) incompatible donor liver.
- Patient has fulminant liver failure with a life expectancy without a liver transplant of less than 7 days as defined by UNOS (Adult Patient Status 1, UNOS Policy 3.6.4.1: See Appendix C).
- Patient has renal dysfunction pre-transplant that, in the opinion of the investigator, will prohibit the use of calcineurin inhibitors within 72 hours post transplant.
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 |
|---|---|---|
| DaclizumubAlso: Zenapaxanti-rejection drug | Drug | daclizumub, MMFand tacrolimus, tacrolimus and cyclosporine |
| TacrolimusAlso: Prografanti rejection drug | Drug | MMF, tacrolimus and cyclosporine, daclizumub, MMFand tacrolimus, tacrolimus and cyclosporine |
| CyclosporineAlso: Neoralanti rejection drug | Drug | MMF, tacrolimus and cyclosporine |
| MMFAlso: mycophenolate mofetilanti rejection drug | Drug | MMF, tacrolimus and cyclosporine, daclizumub, MMFand tacrolimus |
Primary outcome
Freedom From Acute Rejection or HCV Recurrence or Treatment Failure
Time frame: 12 months
Freedom from acute rejection (Banff>grade 2 with RAI score>4) or freedom from HCV recurrence (Batts/Ludwig>Stage 2, or >Grade 3) that requires HCV antiviral therapy or treatment failure (patient death, graft loss, premature withdrawal from study regimen or treatment with more than 1 dose of corticosteroids for presumptive rejection without a biopsy to confirm the rejection; reported values represent the "Number of participants with Freedom From Acute Rejection or HCV Recurrence or Treatment Failure"
Freedom From HCV Recurrence Within First Year That Requires HCV Antiviral Therapy and Freedom From Treatment Failure
Time frame: 12 month post transplant
Participants would have their blood drawn and tested for the HCV virus to determine if they had recurrence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No their is not a plan to make individual Participant data available
Related trials for End Stage Liver Disease
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Acute-on-Chronic Liver Failure (ACLF)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
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CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Goran Klintmalm, MD principal investigator
Baylor Univeristy Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daclizumub, Tacrolimus and Cyclosporine in people with End Stage Liver Disease and Hepatitis C, run by Baylor Research Institute 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 4 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 12 Jan 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Acute Rejection or HCV Recurrence or Treatment Failure (time frame: 12 months). The study lists 2 primary outcomes in all. 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 12 Jan 2017.