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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT03309592
Eligibility Criteria:
Inclusion Criteria:
* Child-Pugh Class Class A \& B Cirrhosis
* mPAP ≥35mmHg
* Pulmonary Capillary Wedge Pressure (PWCP) \<15mmHg on Right Heart Catheterization's (RHCs)
* mPAP \> 50mmHg will be considered eligible unless they are World Health Organization (WHO) Functional Class IV
Exclusion Criteria:
* End stage renal disease on hemodialysis (ESRD on HD)
* Renal dysfunction and GFR \< 30
* AST, ALT \> 5 times the upper limit of normal
* Total bilirubin ≥ 6.0
* INR \> 2
* Initially, Child-Pugh Class C patients will be excluded; however, after the first 5 patients are included, if there is no signal of worsening liver function, the protocol may be amended to include patients with Class C cirrhosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03309592
Study Brief:
Protocol Section:
NCT03309592