Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01447628 | IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients | PHASE2 | COMPLETED | 56 | — | — | Mar 29, 2011 | Dec 22, 2017 | Mar 7, 2022 | 5 | China, Germany +1 |
Time measured in seconds from start to end of the endurance bicycle cardiopulmonary exercise testing at 80% of the peak work rate. Peak work rate is determined by that achieved at the baseline incremental cardiopulmonary exercise test (CPET). Note that this was the primary end-point of the European study. Endurance CPET was not done in China.
To be measured by cardiac catheterisation in wood units.
| Arm | Type | Description |
|---|---|---|
| Ferinject or CosmoFer followed by Placebo | ACTIVE_COMPARATOR | IV iron formulation used in Europe - Ferinject - given over 15 minutes IV iron formulation used in China - CosmoFer - over a period of 4 to 6 hours IV Iron given at Week 0, Placebo (saline) given at Week 12. |
| Placebo followed by Ferinject or CosmoFer | PLACEBO_COMPARATOR | Placebo comparator Placebo (saline) given at Week 0, IV Iron given at Week 12. |
| Name | Type | Description |
|---|---|---|
| Saline | DRUG | intravenous, no active drug |
| Ferinject or CosmoFer | DRUG | Intravenous, 1000 mg iron |
* Males or females aged between 16-75 years old * Pulmonary Arterial Hypertension (PAH) which is idiopathic, heritable or associated with anorexigens. * Iron deficiency (TfR levels \> 28.1 nmol/l, where sTfR analysis is available, Ferritin \< 37 ug/l; transferrin saturations \< 16.4%; iron \< 10.3 u...