Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation
1 other identifier
interventional
194
0 countries
N/A
Brief Summary
The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems. The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 14, 2005
CompletedSeptember 1, 2010
August 1, 2010
2.6 years
October 12, 2005
August 31, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-month cumulative incidence of post-surgical graft loss and death
Secondary Outcomes (4)
hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.
Interventions
Eligibility Criteria
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Sponsors & Collaborators
- Novartislead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 14, 2005
Study Start
December 1, 2002
Primary Completion
July 1, 2005
Last Updated
September 1, 2010
Record last verified: 2010-08