BridgeMD
An European multinational study of a personalized approach of human albumin administration in patients with cirrhosis of the liver and complications
EU CTIS ID: 2022-501006-34-00
What this study is testing
The overall objective is to validate the predictive biomarker of treatment response to human albumin therapy in patients with cirrhosis and ascites
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Decompensated liver cirrhosis defined as Child-Pugh score 7-12
- Clinical and/or ultrasound evidenced ascites
- Age above or equal to 18 years
- At least five days since resolution of a decompensation event or any condition requiring hospitalization
You likely can't join if
- Patients with acute or subacute liver failure without underlying cirrhosis
- Refractory ascites as defined by the International Ascites Club
- Existing TIPS
- Portal vein thrombosis
- Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11)
- Current, planned or previous treatment with direct antiviral agents for HCV in the last six months
See the full eligibility criteria
- Decompensated liver cirrhosis defined as Child-Pugh score 7-12
- Clinical and/or ultrasound evidenced ascites
- Age above or equal to 18 years
- At least five days since resolution of a decompensation event or any condition requiring hospitalization
- Patients with acute or subacute liver failure without underlying cirrhosis
- Refractory ascites as defined by the International Ascites Club
- Existing TIPS
- Portal vein thrombosis
- Severe alcoholic hepatitis (Glasgow Alcoholic Hepatitis Score > 11)
- Current, planned or previous treatment with direct antiviral agents for 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 BCLC-0 or BCLC-A
- Hepatic encephalopathy grade III-IV
- Participation in another study within 3 months prior to screening
- Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (NYHA above grade II), severe chronic pulmonary disease (GOLD Score above or equal to grade 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 or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness 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)
- Patients with cirrhosis who develop decompensation in the postoperative period following partial hepatectomy
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.