A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00332462

First received: May 30, 2006

Last updated: March 1, 2011

Last verified: March 2011

History of Changes

Results First Received: December 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Liver Transplantation
Interventions:	Drug: Cyclosporine (Sandimmun® i.v.) Drug: Cyclosporine (Sandimmun® Optoral)

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
Cyclosporine (Sandimmun®)	Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Participant Flow: Overall Study

	Cyclosporine (Sandimmun®)
STARTED	34 ^[1]
Patients Treated With Sandimmun® i.v.	34
Patients Treated With Sandimmun® Optoral	29
COMPLETED	18
NOT COMPLETED	16
Adverse Event	5
Abnormal Lab Value	1
Unsatisfactory therapeutic effect	4
no longer requires study drug	1
Death	3
Graft Loss	2

[1]	Safety and Intention to treat population.

Baseline Characteristics

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Reporting Groups

	Description
Cyclosporine (Sandimmun®)	Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Baseline Measures

	Cyclosporine (Sandimmun®)
Number of Participants [units: participants]	34
Age [units: years] Mean ± Standard Deviation	53.2 ± 9.6
Gender [units: participants]
Female	12
Male	22

Outcome Measures

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1. Primary:

Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation [ Time Frame: 3 months ]

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2. Secondary:

Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation [ Time Frame: 3 or 6 months after transplantation ]

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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:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00332462 History of Changes
Other Study ID Numbers:	COLO400ADE01
Study First Received:	May 30, 2006
Results First Received:	December 13, 2010
Last Updated:	March 1, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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