A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

Official Title: “A Multicenter, Open-label, Exploratory Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine During the First 7 Days Post Transplant Followed by Treatment With Cyclosporine Micro Emulsion in de Novo Liver Transplant Recipients”

The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.

Intervention(s) in this Clinical Trial

• Drug: Cyclosporine (Sandimmun® i.v.)
  • Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
• Drug: Cyclosporine (Sandimmun® Optoral)
  • Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Cyclosporine (Sandimmun®)
  • Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Primary Measures

• Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation
  • Time Frame: 3 or 6 months after transplantation
    Safety Issue?: Yes

Inclusion Criteria

• About to undergo a primary liver transplant (including living donor, split liver).
• Expected to be capable of study participation for full 6 months post-transplantation.
• Allograft biopsies will be possible.

Exclusion Criteria

• The surgery is a multi-organ transplant.
• The patient has previously been transplanted with any other organ.
• The graft derives from a non-heart beating donor.
• Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00332462

Study ID Number: COLO400ADE01

ClinicalTrials.gov Identifier: NCT00332462

Health Authority: Germany: Federal Institute for Drugs and Medical Devices