Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-01-31

Brief Summary

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This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).

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Detailed Description

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Allogeneic hematopoeitic stem cell transplantation (HSCT) is a therapeutic option for patients with malignancies as well as metabolic and genetic diseases. Conditioning regimens given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow engraftment of the stem-cells infused, and to prevent acute versus host disease (aGVHD). Anti-thymocyte globulin (ATG) is one of the immunosuppressive drugs given as a preparative regimen for HSCT. Subjects will be given an ATG infusion daily for 3 days prior to HSCT and serum levels will be collected, as per schedule, with the last sample taken +100 days post-HSCT.

Conditions

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Malignancy Metabolic Disease Genetic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thymoglobulin

Thymoglobulin 7.5 mg/kg/course prior to HSCT

Group Type EXPERIMENTAL

Thymoglobulin (rATG)

Intervention Type BIOLOGICAL

Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.

Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy.

Interventions

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Thymoglobulin (rATG)

Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.

Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy.

Intervention Type BIOLOGICAL

Other Intervention Names

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Anti-thymocyte Globulin (Rabbit)

Eligibility Criteria

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Inclusion Criteria

* All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the preparative regimen for HSCT, as determined by the responsible HSCT physician.
* Written, informed consent

Exclusion Criteria

* Hypersensitivity to rabbit proteins or to any product excipients
* Active acute or chronic infections, which would contraindicate any additional immunosuppression
* Known pregnancy or breastfeeding

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No