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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT01733095
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with portal hypertension, age \>18 years
* Cirrhosis of any etiology; Child-Pugh class A and B
* Noncirrhotic portal hypertension (e.g. chronic portal vein thrombosis)
* Informed consent
Exclusion Criteria:
* Presence of other causes for pulmonary arterial hypertension
* History of pulmonary embolism or myocardial infarction within 6 months before study start
* Child-Pugh class C
* Presence of hepatocellular carcinoma
* Liver transplantation
* HIV infection
* Severe obstructive or restrictive pulmonary disease (predicted FEV1 or VC \<65%, respectively)
* Severe dilated cardiomyopathy (EF \<50%)
* Latent left-heart insufficiency
* Pregnancy and lactation
* Esophageal variceal hemorrhage within the last 6 months
* Refractory ascites
* Hepatorenal syndrome
* Persistent hepatic encephalopathy \> grade 1
* Bilirubin \>3.0 mg/dl
* AST and/or ALT \>3x ULN
* Creatinine \>2.0 mg/dl
* Known hypersensitivity to ambrisentan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01733095
Study Brief:
Protocol Section:
NCT01733095