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Long-term Albumin in Advanced Cirrhosis
NCT00968695Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2009
- Primary completion
- Apr 2014
- Countries
- 1
- Sponsor
- Grifols
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- human albumin
- Conditions
- Cirrhosisascites
01
Overview
Phase 4, open-label, single-arm trial of human albumin in Cirrhosis and ascites, sponsored by Grifols. Primary endpoints: Change from Baseline plasma renin concentration at 20 weeks, Change from Baseline plasma concentration of noradrenaline at 20 weeks and 6 more. Started Jul 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Albumin
Patients receive weekly albumin infusions for 12 weeks.
03
Who it enrols
Patients with advanced cirrhosis and ascites requiring diuretics, with signs of renal dysfunction but without refractory ascites, organic renal insufficiency, or severe comorbidities.
04
Endpoints
Primary
Change from Baseline plasma renin concentration
Change from Baseline plasma concentration of noradrenaline
Change from Baseline glomerular filtration rate
Change from Baseline cardiac output
Change from Baseline cardiopulmonary pressures
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