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Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Instituto Grifols, S.A..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Joan Albert Arnaiz, Instituto Grifols, S.A.
ClinicalTrials.gov Identifier:
NCT00968695
First received: August 28, 2009
Last updated: November 6, 2012
Last verified: November 2012

August 28, 2009
November 6, 2012
July 2009
January 2014   (final data collection date for primary outcome measure)
  • To asses plasma renin activity and plasma concentration of noradrenaline [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Glomerular filtration [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Portal hypertension [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Cardiac Function [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00968695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.
Clinical Trial on the Effects of Long Term Administration of 20% Albumin in the Cardiovascular and Renal Function, And Hepatic Hemodynamics in Advanced Patients With Cirrhosis and Ascites.

Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged administration of human albumin in the cardiocirculatory and renal function and hepatic hemodynamics in patients with advanced cirrhosis and ascites.

Not Provided
Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cirrhosis
  • Ascites
Drug: Albumin
The pattern of administration of 20% human albumin is 1'5g/kg every week to infuse in 6 hours with a minimum of 90 g up to 150 g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.
Experimental: Albumin
Intervention: Drug: Albumin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age above 18 years and less than 80 years.
  • Diagnosis of liver cirrhosis by biopsy or by clinical, laboratory, or ultrasound.
  • Daily requirement of diuretics at least 200mg of spironolactone or 100mg of spironolactone and 40 mg of furosemide
  • Renal dysfunction defined by a plasma concentration of serum creatinine ≥ 1.2 mg / dl, BUN ≥ 25 mg / dl or a serum sodium concentration ≤ 130 mEq / L.

Exclusion Criteria:

  • Refractory Ascites (paracentesis requirements over 1 month.
  • Neoplastic disease including liver cancer if it exceeds the Milan criteria (one nodule> 5 cm or three nodules> 3 cm).
  • History of transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt
  • Gastrointestinal bleeding or bacterial infection documented in the past 15 days.
  • Heart failure or structural heart disease.
  • Organic renal insufficiency(proteinuria, hematuria and / or ultrasound data nephropathy).
  • Moderate or severe lung chronic disease.
  • Transplant.
  • Infection with human immunodeficiency virus.
  • Active addiction to drugs.
  • Mental state that prevents the patient understand the nature, extent and consequences of the study, except for hepatic encephalopathy.
  • Pregnancy.
Both
18 Years to 80 Years
No
Contact: Joan Albert Arnaiz, MD 0034932279838 jaarnaiz@clinic.ub.es
Contact: Laura Núnez, M Sc 0034935710700 laura.nunez@grifols.com
Spain
 
NCT00968695
IG0802
No
Joan Albert Arnaiz, Instituto Grifols, S.A.
Joan Albert Arnaiz
Hospital Clinic of Barcelona
Principal Investigator: Vicente Arroyo, MD Hospital Clínic of Barcelona
Instituto Grifols, S.A.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP