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The study was closed before 2017 due to inconclusive results from Lab
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymoglobulin | Experimental | Thymoglobulin 7.5 mg/kg/course prior to HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin (rATG) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course | ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured | 100 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tal Schechter-Finkelstein, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thymoglobulin | Thymoglobulin 7.5 mg/kg/course prior to HSCT 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thymoglobulin | Thymoglobulin 7.5 mg/kg/course prior to HSCT 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course | ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured | Blood samples for ATG concentration determination were obtained at 0, +1, +4, +7, +14, +28, +60, +75 and +100 days post-HSCT. ATG serum concentrations were analyzed using a validated immunoassay. ATG pharmacokinetic parameters were estimated using a noncompartmental model. The relationship between HSCT outcomes | Posted | Mean | Standard Deviation | mg/L | 100 days |
|
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This is a pharmacokinetic study. There was no risk for the patients for measuring drug levels.
Adverse Events were not monitored/assessed for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thymoglobulin | Thymoglobulin 7.5 mg/kg/course prior to HSCT 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tal Schechter-Finkelstein | Sickkids | 4168136906 | tal.schechter-finkelstein@sickkids.ca |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008659 | Metabolic Diseases |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |