EUCTR2008-000625-19-ITActive, not recruitingNot Applicable
The use of human albumin for the treatment of ascites inpatients with hepatic cirrhosis:A multicenter, open-label randomized clinical trial. - FARM6P824B
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 sitesStarted: July 15, 2008Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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