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:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT05056220
Eligibility Criteria:
Inclusion Criteria:
* Decompensated liver cirrhosis defined as Child-Pugh score 7-12
* Clinical and/or ultrasound evidenced ascites
* Age ≥ 18 years
* At least five days since resolution of a decompensation event or any condition requiring hospitalisation
Exclusion Criteria:
* Patients with acute or subacute liver failure without underlying cirrhosis
* Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
* Refractory ascites as defined by the International Ascites Club
* Existing TIPS
* Portal vein thrombosis
* Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score \> 11)
* Hepatic encephalopathy grade III-IV
* Current, planned or previous treatment with direct antiviral agents for hepatitis C virus (HCV) in the last six months Contraindications for human albumin infusion (pulmonary oedema, hypersensitivity etc.)
* Evidence of current malignancy except for non-melanocytic skin cancer and hepatocellular carcinoma within Barcelona Clinic Liver Cancer (BCLC)-0 or BCLC-A
* Presence or history of severe extra-hepatic diseases (e.g.,chronic renal failure requiring hemodialysis, severe heart disease (NYHA \> II); severe chronic pulmonary disease (GOLD Score ≥ C), severe neurological and psychiatric disorders, pulmonary arterial hypertension)
* HIV positive or other condition associated with and/or requiring immunosuppression
* Previous liver or other transplantation
* Pregnancy
* Breastfeeding
* Patients who decline to participate, patients who cannot provide prior written informed consent due to other causes than hepatic encephalopathy or patients with hepatic encephalopathy who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker or sufficient ability to provide delayed informed consent
* Physician's denial (investigator considers that the patient will not adhere to the study protocol scheduled, e.g. in case of heavy drinking)
* Participation in another study within 3 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05056220
Study Brief:
Protocol Section:
NCT05056220