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rhIGF-I
IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome
Ensayo de INSMED Inc en sindrome de insensibilidad a la hormona del crecimiento (GHIS) · sindrome de Laron.
- Fase
- Fase 2/3
- Estado
- Completado
- Centros
- 15
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto.
Cómo lo describe el promotor
En el documentoEn inglés, del registroSTUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.
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| Treprostinil Palmitil | Fase 2/3 | En marcha, sin reclutar | dic 2026 (prevista) |
| Treprostinil Palmitil… | Fase 1 | Reclutando pacientes | feb 2027 (prevista) |
| INS1033 | Fase 1 | Reclutando pacientes | mar 2027 (prevista) |
| INS1201 · ASCEND | Fase 1 | En marcha, sin reclutar | ene 2028 (prevista) |
| PALM-PAH | Fase 3 | Reclutando pacientes | dic 2028 (prevista) |
| PALM-ILD | Fase 3 | Reclutando pacientes | dic 2028 (prevista) |
Todos los de INSM, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00368173), actualizada en sep 2012.