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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00332462
First received: May 30, 2006
Last updated: March 1, 2011
Last verified: March 2011

May 30, 2006
March 1, 2011
May 2006
April 2008   (final data collection date for primary outcome measure)
Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.
Incidence of biopsy proven acute rejection during the first 3 months post de novo liver transplantation.
Complete list of historical versions of study NCT00332462 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.
Incidence, safety and tolerability of cyclosporine i.v. during 6 months post de novo liver transplantation
Not Provided
Not Provided
 
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Transplantation
  • 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.
    Other Name: Sandimmun
  • 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.
    Other Name: Sandimmun
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.
Interventions:
  • Drug: Cyclosporine (Sandimmun® i.v.)
  • Drug: Cyclosporine (Sandimmun® Optoral)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2009
April 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00332462
COLO400ADE01
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP