2-Iminobiotin vas a treatment for neonates born with severe oxygen shortage at birth

Phase 1

• Conditions: Perinatal asphyxia; MedDRA version: 19.0Level: LLTClassification code 10003500Term: Asphyxia neonatalSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0Level: LLTClassification code 10070512Term: Hypoxic-ischemic encephalopathySystem Organ Class: 100000004852; MedDRA version: 19.0Level: PTClassification code 10028923Term: Neonatal asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0Level: LLTClassification code 10004943Term: Birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0Level: HLTClassification code 10028946Term: Neonatal hypoxia and asphyxiaSystem Organ Class: 100000004868; MedDRA version: 19.0Level: LLTClassification code 10021147Term: Hypoxic encephalopathySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 19.0Level: LLTClassification code 10022820Term: Intrauterine hypoxia and birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 19.0Level: LLTClassification code 10040441Term: Severe birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2015-003063-12-Outside-EU/EEA
• Lead Sponsor: europhyxia B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-14
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 94

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified