Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
Public ClinicalTrials.gov record NCT00135694. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial to Assess the Safety of Immunosuppression Withdrawal in Liver Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus (HCV), these medications may increase the risk of HCV infection in the transplanted liver. The purpose of this study is to determine whether a slow withdrawal of immune system-suppressing medications is safe in two groups of subjects: those who receive a liver transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral causes of liver failure. The study will also look at whether slow withdrawal will help reduce the long-term side effects of immune system-suppressing medications and decrease the chance for HCV infection of the new liver in transplant patients with HCV.
Study identification
- NCT ID
- NCT00135694
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 275 participants
Conditions and interventions
Interventions
- calcineurin inhibitor-based immunosuppression Drug
- liver transplant Procedure
- corticosteroids Drug
- immunosuppression withdrawal Other
Drug · Procedure · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2005
- Primary completion
- Aug 31, 2015
- Completion
- Aug 31, 2015
- Last update posted
- Feb 3, 2019
2005 – 2015
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | — |
| University of Colorado | Denver | Colorado | 80262 | — |
| Northwestern University | Chicago | Illinois | 60208 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Baylor University | Dallas | Texas | 76798 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00135694, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2019 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00135694 live on ClinicalTrials.gov.