Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01028651
Eligibility Criteria:
Inclusion Criteria:
* Patients must:
1. Had portal hypertension.
2. Be otherwise suitable candidates for OLT.
3. Had severe pulmonary arterial hypertension (PAH) defined as a resting mean pulmonary arterial pressure (mPAP) \>35 mmHg and pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) by right heart catheterization (RHC) performed as part of standard of care evaluation within 90 days of enrollment.
4. Treprostinil therapy must be recommended by the treating physician per standard of care.
5. Be NYHA Functional Class II, III, or IV.
6. Had pulmonary capillary wedge (PCW) pressure ≤18 mmHg and transpulmonary gradient (TPG) ≥15 mmHg.
Exclusion Criteria:
* Patients must not:
1. Had received any any investigational therapy as part of a clinical trial for any indication within 30 days prior to enrollment.
2. Had a change in dose of treatment for PAH (bosentan \[Tracleer\], ambrisentan \[Letairis\], tadalafil \[Adcirca\], or sildenafil \[Revatio\]), within 30 days prior to enrollment. That is, subjects may have been treated with any of these agents provided the dose was stable for at least 30 days prior to enrollment.
3. Had renal failure requiring hemodialysis.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01028651
Study Brief:
Protocol Section:
NCT01028651