Trial Outcomes & Findings for Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants (NCT NCT01135537)

Results Overview

ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

100 days

Results posted on

2019-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	30
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thymoglobulin n=17 Participants 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.
Age, Categorical <=18 years	17 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days

Population: 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

ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured

Outcome measures

Outcome measures
Measure	Thymoglobulin n=17 Participants 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.
Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course	7.86 mg/L Standard Deviation 2.9

Adverse Events

Thymoglobulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Tal Schechter-Finkelstein

Sickkids

Phone: 4168136906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place