Phase 4 Completed N=40 Treatment

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Liver Transplantation

Source: ClinicalTrials.gov NCT00374231 ↗

Enrolled (actual)

Serious AEs

22.5%

Results posted

Dec 2015

Primary outcomePrimary: Incidence of Biopsy Confirmed Acute Rejection at 12 Months. — 5 participants

Summary

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Biopsy Confirmed Acute Rejection at 12 Months.	5	—
SECONDARY Patient Survival.	39	—

Eligibility Criteria

Inclusion Criteria

Greater than 90 days post transplant.
Free from rejection within the last 30 days.
Patient with primary diagnosis of AIH will be evaluated on an individual basis.
Negative pregnancy test.
Practicing an acceptable method of birth control.
Capable of providing written informed consent.

Exclusion Criteria

Rejection within the last 30 days.
Patients with AIH unable to discontinue corticosteroids.
Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
Known sensitivity or contraindication to tacrolimus or MMF.
Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
Pregnant or lactating.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00374231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.