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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.


- candidate number22211
- NTR NumberNTR5221
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-mei-2015
- Secondary IDs14-671; NL50996.041.14 METC; ABR
- Public TitleA 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.
- Scientific Title2-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 36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia
- ACRONYM2-STEP
- hypothesisTo explore the short term safety and tolerability of 2-IB and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia
- Healt Condition(s) or Problem(s) studiedPerinatal asphyxia
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2015
- planned closingdate1-jan-2017
- Target number of participants12
- InterventionsAdministration of the study drug, blood sampling
- Primary outcomeSafety 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 outcomeTo 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.
- TimepointsSafety assessments will be recorded during treatment period of 2-iminobiotin and will continue for at least 96 hours or until discharge from the hospital Blood sampling for pharmacokinetic assessment will occur during the treatment period of 2-iminobiotin and shortly thereafter

MRI(incl DWI):3-7 days after birth. aEEG: will be recorded before start treatment till at least 72 hours after birth.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. F. Groenendaal
- CONTACT for SCIENTIFIC QUERIESDr. F. Groenendaal
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Neurophyxia BV
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-mei-2015 - 30-jul-2015


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