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

Novartis

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332462

COLO400ADE01

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Cyclosporine (Sandimmun®)

Experimental group

Description:

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.

Treatment:

Drug: Cyclosporine (Sandimmun® Optoral)

Drug: Cyclosporine (Sandimmun® i.v.)