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

NCT00332462 | Completed Phase 4 Results

• 1 other identifier: COLO400ADE01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplantation

Keywords

Liver transplantation, Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation

  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.

  3 months

Secondary Outcomes (1)

• Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation

  3 or 6 months after transplantation

Study Arms (1)

Cyclosporine (Sandimmun®)

EXPERIMENTAL

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.

Drug: Cyclosporine (Sandimmun® i.v.); Drug: Cyclosporine (Sandimmun® Optoral)

Interventions

Cyclosporine (Sandimmun® i.v.) DRUG

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.

Also known as: Sandimmun

Cyclosporine (Sandimmun®)

Cyclosporine (Sandimmun® Optoral) DRUG

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.

Also known as: Sandimmun

Cyclosporine (Sandimmun®)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigational Site

Various Cities, Germany

Location

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: January 1, 2009
• Last Updated: March 7, 2011
• Results First Posted: January 11, 2011

Record last verified: 2011-03

Locations

DE (1)