Myfortic Conversion Trial in OLT Recipients With GI Intol... | NCT00619216

Studies
Myfortic Conversion Trial in OLT Recipients With GI Intolerance

NCT00619216

Sponsor

University of North Carolina, Chapel Hill

Status

Completed

Last Update Posted

Jun 3, 2011Estimated

Enrollment

31Actual

Phase

Not provided

Conditions

GI Disturbance

Interventions

Mycophenolic Acid (Myfortic)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 7, 2008

First Submission Date that Met QC Criteria

Feb 19, 2008

First Posted Date

Feb 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2011

Last Update Posted Date

Jun 3, 2011Estimated

Name	Class
Novartis Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolic Acid (Myfortic)	Drug	Equimolar conversion from mycophenolate mofetil to mycophenolic acid		Cellcept; Myfortic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipients of orthotopic liver transplant at least 8 weeks post transplant
Mild and/or moderate GI complaints directly related to MMF

Exclusion Criteria:

Multi-organ transplant recipients
Evidence of graft rejection within 14 days prior to Baseline visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Recipients of Orthotopic Liver Transplants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Gerber, MD	UNC-Chapel Hill Department of Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina-Chapel Hill		Chapel Hill	North Carolina	27599-7211	United States

Intervention Browse Module

MeSH Terms

ID	Term
D009173	Mycophenolic Acid

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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Browse Branches

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