Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

McGill University

Status and phase: Unknown; Phase 3

Conditions: Heart Transplant Patients

Treatments: Drug: Myfortic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00468936

BMB 06-006

OCC 2006-104

Details and patient eligibility

About

Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable dose MMF for at least 4 weeks
• Over 18 years of age
• Heart transplant at least three months prior to study

Exclusion criteria

• GI symptoms known not to be caused by MPA therapy
• Acute rejection episode in past 4 weeks
• History of malignancy since transplant
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

No Intervention group

Description:

Usual medications (Cellcept)

2

Active Comparator group

Description:

Patients taking Myfortic

Treatment:

Drug: Myfortic