A study looking at 2-Iminobiotin as treatment for newborn children suffering from insufficient oxygen supply to the brain in addition to standard treatment with cooling.

2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of ¡Ý36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20368

Enrollment

Registered

2015-05-19

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perinatal asphyxia - perinatale asfyxie

Interventions

Administration of the study drug, blood sampling

Eligibility

Inclusion criteria

Inclusion criteria: 1. Neonates with ≥ 36 and <44 weeks gestation who are eligible to receive therapeutic hypothermia. 2. Ability to start treatment within 12 hours after birth.

Exclusion criteria

Exclusion criteria: 1. Inability to insert an indwelling catheter (umbilical venous catheter or percutaneously inserted central catheter, preferably multiple lumen) for administration of the drug or an arterial line for recurrent blood sampling. 2. Major congenital malformations, specifically malformations that may affect the renal function.

Design outcomes

Primary

Measure	Time frame
Safety assessments include: vital signs, clinical laboratory parameters, clinical evaluation and (severe) adverse events and local tolerance. Pharmacokinetic assessment: a maximum of five PK samples will be taken. The exact time points to determined before start of the study based on all data available at that moment. The following pharmacokinetic parameters will be calculated for each patient, using the actual sampling times: • C-max (observed maximum plasma concentration) • AUC-0-6h (area under the plasma concentration-time curve from time 0 to 6h after administration) • AUC-0-∞ (area under the plasma concentration-time curve from time 0 to infinity) • T-end of infusion (time at maximum plasma concentration). •t1/2 (terminal elimination half-life) •CL (clearance) •Vd (volume of distribution)	—

Measure

Time frame

Safety assessments include: vital signs, clinical laboratory parameters, clinical evaluation and (severe) adverse events and local tolerance. Pharmacokinetic assessment: a maximum of five PK samples will be taken. The exact time points to determined before start of the study based on all data available at that moment. The following pharmacokinetic parameters will be calculated for each patient, using the actual sampling times: • C-max (observed maximum plasma concentration) • AUC-0-6h (area under the plasma concentration-time curve from time 0 to 6h after administration) • AUC-0-∞ (area under the plasma concentration-time curve from time 0 to infinity) • T-end of infusion (time at maximum plasma concentration). •t1/2 (terminal elimination half-life) •CL (clearance) •Vd (volume of distribution)

—

Secondary

Measure	Time frame
•To gather preliminary signs of short term efficacy as defined by the Lac/NAA ratios using MRS at 3-7 days after birth and the percentage of surviving patients with a normal aEEG at 60h after birth.	—

Contacts

Public ContactF. Groenendaal

UMC Utrecht - Wilhelmina Kinderziekenhuis

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)