The use of human albumin for the treatment of ascites inpatients with hepatic cirrhosis:A multicenter, open-label randomized clinical trial. - FARM6P824B

Conditions: ascites in patients with hepatic cirrhosis
MedDRA version: 9.1Level: LLTClassification code 10003445Term: Ascites

Registration Number: EUCTR2008-000625-19-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic and
ultrasonographic features) and uncomplictaed ascites according to the criteria of the
International Ascites Club (1).
- Diuretic treatment, stable for at least 7 days prior the enrollemnt, with an antimineralocorticoid
drug at a dose ≥ 200mg/day and furosemide ≥ 25mg/day. With this
limitation, we aim to identify a fairly homogeneous population with a relatively
advanced stage of the disease that will likely have more benefit from albumin
administration, as also suggested by Gentilini at al. (17).
- EGDS performed in the last 12 months, abdominal ultrasonography performed in the
last 30 days, and laboratory tests required by the protocol in the last 7 days.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age lower than 18 years
- No written informed consent
- Inability to follow written consent
- Ongoing alcohol abuse (patients should be abstinent for at least three monts)
- Established diagnosis of refractory ascites, as defined by the IAC (1)
- Need of 3 or more paracentesis during the last two months
- Serum creatinine > 1.6 mg/dl
- Patients with TIPS or other surgical porto-caval shunts
- Budd-Chiari Syndrome
- Previous liver transplantation
- Known hepatocellular carcinoma or other malignancies
- Current / recent gastrointestinal bleeding, bacterial infection or type 1 hepatorenal syndrome
- Renal failure due to intrinsic nephropathy
- Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis)
- Known or suspected hypersensitivity to albumin
- Pregnancy and breast-feeding
- Use of experimental drugs for the last 2 months prior the inclusion in the present study
- Females of child-bearing potential are excluded unless they meet one of the
following criteria:
o Post-menopausal for 6 months or more, and if post-menopausal for less
than 2 years, a negative pregnancy test
o Surgical sterilisation for more than one month duration and a negative
pregnancy test
o Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or
spermicide) and a negative pregnancy test

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objectives are:<br>- increase in survival<br>- improvement in the response to standard medical treatment and avoid/delay the<br>occurrence of refractory ascites in patients with cirrhosis and uncomplicated ascites.;Secondary Objective: Secondary objectives are:<br>- to avoid/delay the need of transjugular intrahepatic porto-systemic shunt in patients<br>with refractory ascites<br>- reduction in the incidence of disease- and/or diuretic-related complications<br>- improvement in the quality of life<br>- reduction of the costs of patient management.;Primary end point(s): Primary outcomes.<br>1) reduction in the 24 month mortality;<br>2) reduction in the 24 month incidence of refractory ascites

Secondary Outcome Measures