PACTR202308870380725尚未招募2 期
TIBC-II: Multicenter phase II trial comparing efficacy of 2-iminobiotin (2-IB) treatment with standard care in neonates =36 weeks gestational age with moderate to severe perinatal asphyxia in Kinshasa, DR Congo
niversity Clinics Kinshasa0 个研究点目标入组 86 人开始时间: 2023年8月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 Day(s) 至 1 Month(s)（—）
- 性别
- All
入选标准
- •1. Newborns with = 36 weeks gestation with moderate to severe perinatal asphyxia with a Thompson score = 7 and < 16 within 6 hours of birth
- •2. Possibility to start treatment within 6 hours after birth
排除标准
- •1.Inability to insert an umbilical venous catheter or peripheral infusion for study medication administration.
- •2.Major congenital or chromosomal abnormalities, such as diaphragmatic hernia, omphalocele, trisomy 13 or trisomy 18
- •3.Birth weight< 1800 grams
- •4.Obvious signs of infection
- •5.Moribund patients
研究者
相似试验
进行中（未招募）
1 期
2-Iminobiotin vas a treatment for neonates born with severe oxygen shortage at birthPerinatal asphyxiaMedDRA version: 19.0Level: LLTClassification code 10003500Term: Asphyxia neonatalSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.0Level: PTClassification code 10028923Term: Neonatal asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.0Level: LLTClassification code 10004943Term: Birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.0Level: HLTClassification code 10028946Term: Neonatal hypoxia and asphyxiaSystem Organ Class: 100000004868MedDRA version: 19.0Level: LLTClassification code 10021147Term: Hypoxic encephalopathySystem Organ Class: 100000004852MedDRA version: 19.0Level: LLTClassification code 10022820Term: Intrauterine hypoxia and birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.0Level: LLTClassification code 10040441Term: Severe birth asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.0Level: LLTClassification code 10070512Term: Hypoxic-ischemic encephalopathySystem Organ Class: 100000004852EUCTR2015-003063-12-Outside-EU/EEAeurophyxia B.V.94
进行中（未招募）
1 期
A multicentre Phase IIb study to evaluate the efficacy and tolerability of ModraDoc006/r in patients with a type Prostate Cancer (mCRPC), suitable for treatment with a taxane.metastatic Castration Resistant Prostate CancerMedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2019-000582-21-CZModra Pharmaceuticals B.V.100
进行中（未招募）
1 期
A multicentre Phase IIb study to evaluate the efficacy and tolerability of ModraDoc006/r in patients with a type Prostate Cancer (mCRPC), suitable for treatment with a taxane.metastatic Castration Resistant Prostate CancerMedDRA version: 20.0Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2019-000582-21-HUModra Pharmaceuticals100
进行中（未招募）
1 期
A multicentre Phase IIb study to evaluate the efficacy and tolerability of ModraDoc006/r in patients with a type Prostate Cancer (mCRPC), suitable for treatment with a taxane.EUCTR2019-000582-21-DEModra Pharmaceuticals100
进行中（未招募）
1 期
A multi-centre phase II trial to assess the efficacy of epirubicin, cisplatin and capecitabine incorporating the prospective validation of molecular classifiers and exploratory metabonomics. - CUP ONEMetastatic Carcinomas of Unknown Primary origin (CUP)EUCTR2008-000657-35-GBGreater Glasgow and Clyde Health Board (GGCHB)/University of Glasgow59