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rhIGF-I/rhIGFBP-3 · 1 trial · 1 indication
ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).
| Arm | Type | Description |
|---|---|---|
| rhIGF-I/rhIGFBP-3 | ACTIVE_COMPARATOR | Continuous IV Infusion |
| Control | NO_INTERVENTION | The comparator group will receive no treatment with rhIGF-1/rhIGFBP-3 |
| Name | Type | Description |
|---|---|---|
| rhIGF-I/rhIGFBP-3 | DRUG | Continuous intravenous infusion |
Inclusion Criteria: * Signed informed consent from parents/guardians; * Subject must be between GA of 26 weeks + 0 days and 27 weeks + 6 days (Study Section A) or between GA of 23 weeks + 0 days and 27 weeks + 6 days (Study Sections B, C, and D), inclusive Exclusion Criteria: * Subjects born smal...
rhIGF-I/rhIGFBP-3 is an investigational small molecule being studied for the prevention of Retinopathy of Prematurity (ROP), a condition affecting premature infants. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
rhIGF-I/rhIGFBP-3 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in preventing Retinopathy of Prematurity.
rhIGF-I/rhIGFBP-3 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for Retinopathy of Prematurity.
rhIGF-I/rhIGFBP-3 has one completed Phase 2 clinical trial, NCT01096784, titled 'IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity'. This trial enrolled 121 participants and was conducted in the United States, Italy, Netherlands, Poland, Sweden, and the United Kingdom.
Yes, rhIGF-I/rhIGFBP-3 is also known as IGF-1/IGFBP3. The clinical trial NCT01096784, which studies this drug for Retinopathy of Prematurity, uses the title 'IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity', confirming the alternative name.