Unique ID issued by UMIN | UMIN000018226 |
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Receipt number | R000021096 |
Scientific Title | Phase III study of Efficacy, Safety and Pharmacokinetics of SJP-0129 in the Treatment for Patent Ductus Arteriosus |
Date of disclosure of the study information | 2015/07/31 |
Last modified on | 2016/07/28 09:34:30 |
Phase III study of Efficacy, Safety and Pharmacokinetics of SJP-0129 in the Treatment for Patent Ductus Arteriosus
Efficacy, Safety and Pharmacokinetics of SJP-0129 for Patent Ductus Arteriosus
Phase III study of Efficacy, Safety and Pharmacokinetics of SJP-0129 in the Treatment for Patent Ductus Arteriosus
Efficacy, Safety and Pharmacokinetics of SJP-0129 for Patent Ductus Arteriosus
Japan |
Patent Ductus Arteriosus
Cardiology | Pediatrics | Intensive care medicine |
Others
NO
This study aimed to determine the efficacy, safety and pharmacokinetics of treatment with intravenous SJP-0129 for Patent Ductus Arteriosus.
Efficacy
The proportion of infants that required rescue treatment on or prior to Study Day 14.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
SJP-0129 is given by 3 times at 24 intervals with intravenous injection.
Not applicable |
Not applicable |
Male and Female
1) Subjects with a birth weight of 500 to 1,500 grams, up to 32 weeks gestational age.
2) Less than 72 hours of age at the time of administration of SJP-0129.
3) One of the eldest infant in the case of multiple births. If he/she does not meet the eligibility criteria, the second infant will be included.
4) Written informed consent by legal representative.
1) Any major congenital malformations.
2) Any hyperbilirubinemia.
3) Less than 0.6 mL/kg/hr of baseline urinary output.
4) Any bleeding tendency from puncture sites.
5) Subjects with complicated with coagulation disorder.
6) Subjects with complicated with intraventricular hemorrhage.
7) Subjects with thrombopenia.
8) Subjects with suspected necrotizing enterocolitis.
9) Any major congenital malformations and/or chromosomal anomalies.
10) Any severe congenital bacterial infection.
11) Use of maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery.
12) Treatment with steroid or NSAID therapy since birth.
13) Subject with unremitting shock requiring very high doses of vasopressors.
14) Subjects with expected survival less than 48 hours.
15) Participation in any other clinical study.
20
1st name | |
Middle name | |
Last name | Shinya Hirano |
Osaka Medical Center and Research Institute for Matemal and Child Health
Department of Neonatal Medicine
840, Murodocho, Izumi, Osaka, Japan
0725-56-1220
hiranos@snow.odn.ne.jp
1st name | |
Middle name | |
Last name | Shogo Sameshima |
Senju Pharmaceutical co.,ltd.
Regulatory Affairs & Medical Writing, Clinical Development
2-5-8, Hirano-machi, Chuo-ku, Osaka, Japan
06-6201-9605
shogo-sameshima@senju.co.jp
Senju Pharmaceutical co.,ltd.
Senju Pharmaceutical co.,ltd.
Profit organization
NO
2015 | Year | 07 | Month | 31 | Day |
Unpublished
Completed
2015 | Year | 06 | Month | 24 | Day |
2015 | Year | 08 | Month | 01 | Day |
2015 | Year | 07 | Month | 07 | Day |
2016 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021096
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