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Inhaled Treprostinil
An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
Ensayo de UNITED THERAPEUTICS Corp en Pulmonary Hypertension · Interstitial Lung Disease · Combined Pulmonary Fibrosis and Emphysema (del registro, en inglés).
Más ensayos de: Hipertensión pulmonar · Enfermedad pulmonar intersticial.
- Fase
- Fase 2/3
- Estado
- Interrumpido
- Participantes
- 243
- Centros
- 92
- Fin del objetivo primario
- ago 2021
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2016.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Inhaled treprostinil became commercially available in the US following its approval for PH-ILD».
Qué mide
Change in Peak 6-Minute Walk Distance (6MWD) From Baseline (Baseline through Week 124 in RIN-PH-202 (Combined data from parent study RIN-PH-201 [NCT02630316] and this open-label extension study RIN-PH-202)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).
Más ensayos de UTHR
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Parenteral Treprostinil · ARTISAN | Fase 4 | En marcha, sin reclutar | abr 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Ralinepag | Fase 3 | Reclutando por invitación | dic 2026 (prevista) |
| Oral treprostinil · ADAPT | no aplica | En marcha, sin reclutar | mar 2027 (prevista) |
| Inhaled Treprostinil | Fase 3 | Reclutando pacientes | nov 2027 (prevista) |
| 10 GE Xenokidney · EXPAND | Fase 1/2 | Reclutando pacientes | oct 2028 (prevista) |
| GGTA1 KO Thymokidney · EXTEND | Fase 1/2 | Reclutando pacientes | nov 2029 (prevista) |
Todos los de UTHR, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02633293), actualizada en nov 2022.