Trials / Completed
CompletedNCT00295607
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in Hepatitis C Virus (HCV) Positive Liver Transplant Patients
Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
Detailed description
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus | immunosuppression |
| DRUG | steroids, monoclonal anti-IL2R antibody | immunosuppression |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2006-02-24
- Last updated
- 2013-04-11
Locations
17 sites across 8 countries: Czechia, France, Germany, Italy, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00295607. Inclusion in this directory is not an endorsement.