Clinical trial
FITREP-EAP2201
Name
FITREP-EAP2201
Description
This is an Expanded Access Program (EAP) for eligible participants with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) designed to provide access to Inhaled Treprostinil. Availability will depend on territory elegibility.
Trial arms
Treatment
Inhaled Treprostinil
Other names:
Tyvaso
Size
-1
Eligibility criteria
Inclusion Criteria:
1. Patient consent
2. Males and females aged 18 years old or older
3. PH-ILD diagnosis:
* Confirmed diagnosis of Group 3 PH by Right Heart Catheterization (RHC):
- mPAP \> 20 mmHg with PAWP ≤ 15 mmHg and PVR ≥ 2 WU and
* Confirmed diagnosis of diffuse parenchymal lung disease based on imaging (any form of ILD or CPFE)
Exclusion Criteria:
1. Diagnosis of PAH or PH for reasons other than Group 3 PH-ILD
2. Use of concomitant PAH drugs contraindicated for PH-ILD (ambrisentan and riociguat)
3. Use of any concomitant investigational drug
Protocol
{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}
Updated at
2022-10-10
1 organization
1 product
3 indications
Organization
Ferrer InternacionalProduct
TreprostinilIndication
Pulmonary HypertensionIndication
Interstitial Lung Disease