Perinatal asphyxia MedDRA version: 19.0 Level: LLT Classification code 10003500 Term: Asphyxia neonatal System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0 Level: PT Classification code 10028923 Term: Neonatal asphyxia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0 Level: LLT Classification code 10004943 Term: Birth asphyxia System Organ Class: 10038738 - Respiratory, thoracic and mediastinal
Conditions
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
Concentration unit: m
Sponsors
Neurophyxia B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Neonates with = 36 weeks gestation with moderate to severe perinatal asphyxia with a Thompson score = 7 within 6h after birth Ability to start treatment within 6 hours after birth 2.Ability to start treatment within 6 hours after birth Are the trial subjects under 18? yes Number of subjects for this age range: 94 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to insert an umbilical venous catheter for administration of the study drug. 2. Major congenital or chromosomal abnormalities, such as hernia diaphragmatica, omphalocele, trisomy 13 or trisomy 18 3. Birth weight < 1800 grams 4. Clear signs of infection 5. Moribund patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study will consist of two parts, an initial open label pilot part with as main objective to study the pharmacokinetic profile of 2-Iminobiotin (2-IB), followed by a randomised part with as main objective to study the efficacy of 2-IB in a population of new-borns with perinatal asphyxia. ;Secondary Objective: In both the pilot part and the randomised part the safety profile will be evaluated.;Primary end point(s): Pilot part: In an open label pilot part the pharmacokinetic and safety profile will be studied. Results will be used to decide on adjustment of the dose in the randomised part of the study. Randomised part: The short term efficacy will be evaluated as determined by the number of surviving patients with a normal aEEG (continuous normal voltage (CNV)) at 36h after birth.;Timepoint(s) of evaluation of this end point: Pilot Phase: Pharmacokinetic profile will be determined at 5 time points:directly after completion of the first infusion, just before the second and last infusion, and 1h and 4h after the last infusion. Randomised phase: aEEG and mortalitry will be evaluated at 36h after birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In addition to the main efficacy end point described above: several other parameters will be evaluated, including Thompson score, aEEG at other time points, presence of seizures, neuronal markers and neonatal mortality. For evaluation of safety vital signs, need for intervention, basic biochemistry, renal function and (serious) adverse events will be monitored. ;Timepoint(s) of evaluation of this end point: Efficacy end-points: aEEG, Thompson score, neuronal biomarkers at selected time points during first 72 hours after birth; seizures and mortality during first 7 days after birth. Safety end-points: vital signs, blood biochemistry, renal function and need for intervention will be monitored at selected time points within 48 hours after birth; (Serious) Adverse Events will monitored during stay at the NICU for up to a maximum of 7 days. | — |
Countries
Congo, The Democratic Republic of the
Contacts
Public ContactVP Regulatory Affairs
Neurophyxia B.V.
Outcome results
None listed