Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin

NCT00986817 | Completed Phase 3

• 1 other identifier: P071215
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion. In pilot studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites production. Therefore the investigators will study the effect of combined therapy with albumin and terlipressin on recidivation ascites.

Conditions

Cirrhosis

Keywords

Refractory ascites; Cirrhosis Terlipressin; Paracentesis

Outcome Measures

Primary Outcomes (1)

• Mean number of paracentesis between the 2 groups over a 6 months period

  6 months

Secondary Outcomes (6)

• Total ascites retrieval

  6 months

• Number of cirrhosis complications groups

  6 months

• Liver transplantation and deaths

  6 months

• Terlipressin safety

  6 months

• Mean number of days of hospitalization

  6 months

Study Arms (2)

Terlipressin

EXPERIMENTAL

Drug: Terlipressin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Terlipressin DRUG

Albumin perfusions at the dose 8 g/l of removed ascites and Terlipressin (1mg), administrated before and at the end of the paracentesis.

Terlipressin

Placebo DRUG

albumin perfusion at the dose 8 g/l of removed ascites and placebo, administrated before and at the end of the paracentesis.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years old and more with cirrhosis and refractory ascites define by the international ascites club.
• Vital status non engaged in the 2 months

You may not qualify if:

• cardiovascular disease : previous or actual angina pectoralis, myocardial infarction, heart failure, rhythm or conduction disorders, repolarisation abnormality on ECG
• respiratory disease: previous or actual chronic pulmonary insufficiency, asthma
• uncontrolled hypertension
• acute portal vein thrombosis (less then 3 months) or currently treated.
• chronic renal insufficiency (creatin \> 15 mg/L)
• severe hepatic encephalopathy
• Alcoholic hepatitis or gastrointestinal bleeding in the last 3 months
• hepatocellular carcinoma
• severe illness with life threatening
• pregnant or breastfeeding women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CARBONELL Nicolas

Paris, Paris, 75012, France

Location

Related Publications (23)

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  PMID: 9425946 BACKGROUND

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MeSH Terms

Conditions

Fibrosis; Ascites

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Nicolas Carbonell, MD

  Hôpital Saint Antoine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 15, 2015

Record last verified: 2015-06

Locations

FR (1)