Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00149890

First received: September 6, 2005

Last updated: August 17, 2011

Last verified: August 2011

History of Changes

Results First Received: January 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Liver Transplantation Infection
Interventions:	Drug: Basiliximab Drug: Cyclosporine/cyclosporine microemulsion Drug: Steroid

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

With Intraoperative Steroids

Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.

Without Intraoperative Steroids

No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.

Participant Flow: Overall Study

	With Intraoperative Steroids	Without Intraoperative Steroids
STARTED	39 ^[1]	38
COMPLETED	26	20
NOT COMPLETED	13	18
Adverse Event	1	8
Lack of Efficacy	8	9
Protocol Violation	1	0
Lost to Follow-up	1	0
Graft Loss	2	1

[1]	"Started" indicates all screened and treated participants.

Baseline Characteristics

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Reporting Groups

	Description
With Intraoperative Steroids	Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
Without Intraoperative Steroids	No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
Total	Total of all reporting groups

Baseline Measures

	With Intraoperative Steroids	Without Intraoperative Steroids	Total
Number of Participants [units: participants]	39	38	77
Age [units: years] Mean ± Standard Deviation	3.08 ± 4.09	3.71 ± 5.36	3.39 ± 4.74
Age, Customized [units: participants]
<2 years	21	24	45
from 2 to 16 years	18	14	32
Gender [units: participants]
Female	21	19	40
Male	18	19	37

Outcome Measures

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1. Primary:

Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation [ Time Frame: 3 months after treatment ]

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2. Secondary:

Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months [ Time Frame: 3 months ]

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3. Secondary:

Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months [ Time Frame: 3 and 6 months ]

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4. Secondary:

Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation [ Time Frame: 3 months and 6 months ]

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5. Secondary:

Number of Participants With Bacterial, Viral and Fungal Infections During Six Months [ Time Frame: 6 months ]

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6. Secondary:

Time of Onset of a First Biopsy Proven Acute Rejection [ Time Frame: 6 months ]

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7. Secondary:

Percentage of Participants With Treatment Failure Within Three and Six Months [ Time Frame: 3 and 6 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00149890 History of Changes
Other Study ID Numbers:	CCHI621ADE04
Study First Received:	September 6, 2005
Results First Received:	January 20, 2011
Last Updated:	August 17, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut

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