A Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Ciclosporin/Ciclosporin Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients

This study is currently recruiting participants.

Verified by Novartis, December 2008

First Received: September 6, 2005 Last Updated: December 1, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00149890

Purpose

Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, ciclosporin and steroids in pediatric de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.

Condition	Intervention	Phase
Liver Transplantation Infection	Drug: Basiliximab Drug: Ciclosporin/ciclosporin microemulsion	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label, Randomized, Two Arm Study to Investigate the Efficacy and Safety of a Therapy Avoiding Intraoperative Steroids in Combination With Basiliximab, Ciclosporin/Ciclosporin Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Cyclosporine Cyclosporin Basiliximab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of at least one biopsy proven acute rejection episode, graft loss or death within the first three months post-transplantation

Secondary Outcome Measures:

Incidence of biopsy proven acute rejection episodes within the first three months
Incidence of steroid resistant rejection episodes within three and six months
Death or graft loss (defined as being listed for a retransplantation) within three and six months after transplantation
Incidence of bacterial, viral and fungal infections during six months
Time of onset of a first biopsy proven acute rejection

Estimated Enrollment:	80
Study Start Date:	March 2004
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental	Drug: Basiliximab experimental
2: Active Comparator	Drug: Ciclosporin/ciclosporin microemulsion active comparator

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size)
Cadaveric or living donor (related or unrelated)

Exclusion Criteria:

Patients who are recipients of multiple solid organ transplants and/or who have previously received transplanted organs
If cold ischemia time of the transplanted organ is >12 hours
Auxiliary liver transplant recipients

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149890

Contacts

Contact: Novartis

41613241111

Locations

Germany
Novartis Investigational Site	Recruiting
Various Cities, Germany
Contact: Novartis 41613241111

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	novartis ( novartis )
Study ID Numbers:	CCHI621ADE04
Study First Received:	September 6, 2005
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00149890 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

pediatric
liver transplantation
Simulect
Basiliximab

ciclosporin microemulsion
steroid reduction
pediatric liver transplantation

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Infection
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Basiliximab
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009