Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance

NCT01445236 | Terminated DMC

• 1 other identifier: Weaning-Biomarkers
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Immunosuppressive drugs can be successfully withdrawn in a fraction of liver transplant patients. Specific peripheral blood gene expression markers can be employed to select patients with a high likelihood of being tolerant. In the current study the investigators propose to conduct a pilot non-randomized prospective study in which gradual weaning of immunosuppressive drugs will be offered to liver recipients exhibiting a favorable peripheral blood gene expression profile.

Conditions

Liver Transplantation

Keywords

Operational tolerance; Biomarkers; Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients developing operational tolerance

  12 months after complete withdrawal of all immunosuppressive drugs

Study Arms (1)

Weaning patients

EXPERIMENTAL

Other: Immunosuppresion withdrawal

Interventions

Immunosuppresion withdrawal OTHER

Gradual discontinuation of all immunosuppressive drugs.

Also known as: Cyclosporine A, Tacrolimus

Weaning patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver transplant recipients with at least 3 years of post-operative follow-up in whom gene expression pattern changed from non-tolerant to tolerant under sirolimus treatment.
• Feasibility of performing very frequent (every 2-3 weeks) clinical follow-up visits.
• No history of graft rejection during the previous 12 months.
• Basal liver biopsy without signs of rejection
• Stability of liver graft function, defined as: a) normal liver function tests (AST, ALT, ALP, GGT) during at least 6 months; or alternatively b) minor alterations in liver function tests that have not changed over the previous 6 months (AST/ALT \< 2 fold normal levels; ALP \< 1.5 fold normal levels; GGT \< 2 fold normal levels; bilirubin \< 2 mg/dL).
• Signature of informed consent.

You may not qualify if:

• Requirement of immunosuppressive treatment for an indication different to liver transplantation.
• Documented human immunodeficiency virus (HIV) infection.
• Liver-Kidney transplant recipients.
• History of liver autoimmune disease (autoimmune hepatitis, primary liver cirrhosis, primary sclerosing cholangitis)
• Active hepatitis C virus infection as defined by positive serum HCV-RNA.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Cyclosporine; Tacrolimus

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Alberto Sanchez-Fueyo, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director IDIBAPS Transplant Immunology Laboratory

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 3, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

ES (1)