A randomised pilot trial of a steroid-free immunosuppressant regimen in paediatric liver transplantatio

Completed

• Conditions: Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Hepatology; Surgery; Liver transplantation

• Registration Number: ISRCTN49665078
• Lead Sponsor: Birmingham Children's Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Children undergoing primary isolated hepatic transplantation
2. Aged less than or equal to 18 years, either sex
3. Ability to provide informed consent

Exclusion Criteria

1. Children undergoing retransplantation
2. Transplantation for Intestinal failure associated liver disease
3. Multi-organ transplantation
4. Transplantation for autoimmune liver disease
5. Transplantation for extra-hepatic malignancy
6. Pre-existing need for oral steroids, or high-dose inhaled steroids sufficient to require a steroid warning card

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 22/10/2013:<br>The development of histologically proven acute rejection within 12 months.<br><br>Previous primary outcome measures:<br>Development of acute rejection; this can occur at any time post-transplant

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 22/10/2013:<br>1. The development of steroid-resistant acute rejection within 12 months<br>2. The expression of tissue and circulating markers of immune tolerance in the first year post transplant<br>3. The incidence of infection in the first year post transplant<br><br>Previous secondary outcome measures:<br>1. Development of steroid-resistant rejection<br>2. Expression of tissue and circulating markers, analysed in batches. We intend to wait until all the study is closed and all the tests can be run at a single time. This may occur 24 months after the start of the study