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 =36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004265-25-NL

Enrollment

Unknown

Registered

2015-01-19

Start date

2015-04-15

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

Perinatal asphyxia MedDRA version: 19.0 Level: LLT Classification code 10003500 Term: Asphyxia neonatal System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT Classification code 10004943 Term: Birth asphyxia System Organ Class: 100000004855

Interventions

Product Name: 2-Iminobiotin Product Code: NEU-01 Pharmaceutical Form: Solution for infusion INN or Proposed INN: 2-Iminobiotin CAS Number: 13395-35-2 Current Sponsor code: NEU-01 Other descriptive nam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Neonates with = 36 and =65 years) no F.1.3.1 Number of subjects for this age range

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
Main Objective: To explore the short term safety and tolerability of 2-IB and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia;Secondary Objective: •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. ;Primary end point(s): 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-0-8 (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) ;Timepoint(s) of evaluation of this end point: Safety 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	—

Measure

Time frame

Main Objective: To explore the short term safety and tolerability of 2-IB and the pharmacokinetic profile of 2-IB when given on top of therapeutic hypothermia;Secondary Objective: •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. ;Primary end point(s): 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-0-8 (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) ;Timepoint(s) of evaluation of this end point: Safety 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

—

Secondary

Measure	Time frame
Secondary end point(s): •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. ;Timepoint(s) of evaluation of this end point: MRI(incl DWI):3-7 days after birth. aEEG: will be recorded before start treatment till at least 72 hours after birth.	—

Countries

Netherlands

Contacts

Public ContactDepartment of Neonatoloy

University Medical Centre Utrecht

f.groenendaal@umcutrecht.nl31887554544

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026