Liver TransplantPhase 3NCT00238901
Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation
A Phase 3 study testing Basiliximab in people with Liver Transplant, run by Novartis.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Basiliximab
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Jul 2005
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- Adult, Older adult
Inclusion Criteria Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)
Exclusion Criteria Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied
About this study
Official title: Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)
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.
- Conditions
- Liver Transplant
- Being tested
- Basiliximab
- Keywords
- Liver transplant, HCV+, steroid free
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startDec 2002
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238901
- Sponsor's protocol ID
- CCHI621AIT06
- Status last verified
- Aug 2010
- First submitted
- 12 Oct 2005
- Last updated
- 1 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)
- ClinicalTrials.gov ID
- NCT00238901
- Acronym / sponsor ID
- CCHI621AIT06
- Conditions
- Liver Transplant
- Keywords
- Liver transplant, HCV+, steroid free
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2005 (actual)
- First posted
- 14 Oct 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Basiliximab | Drug | – |
Primary outcome
12-month cumulative incidence of post-surgical graft loss and death
4 secondary outcomes
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.
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 1 Sep 2010.
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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.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Basiliximab in people with Liver Transplant, run by Novartis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
12-month cumulative incidence of post-surgical graft loss and death. 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 1 Sep 2010.