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Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients

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Novartis

Status and phase

Completed
Phase 4

Conditions

Liver Transplant

Treatments

Drug: Cyclosporine microemulsion

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171743
COLO400AIT03

Details and patient eligibility

About

The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • At least 4 months post-transplant
  • Patients in treatment with tacrolimus
  • Post-transplant diabetes treated with insulin for at least one month

Exclusion Criteria

  • Known hypersensitivity to cyclosporine microemulsion
  • Investigational drug within 60 days before baseline or during the study
  • Patients who cannot comply with the study requirements

Other protocol-defined exclusion criteria applied

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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