Effect of Pioglitazone on Portal and Systemic Hemodynamics in Patients With Advanced Cirrhosis
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to investigate the response to pioglitazone on the hepatic venous pressure gradient and peripheral vascular responsiveness to vasoconstrictors in patients with advanced (Child´s Grade B or C) cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2004
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 10, 2007
CompletedFirst Posted
Study publicly available on registry
December 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedNovember 25, 2008
November 1, 2008
3.9 years
December 10, 2007
November 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
portal and systemic hemodynamic parameters
9 days
Secondary Outcomes (1)
markers of oxidative stress (malondialdehyde)
9 days
Study Arms (2)
1
ACTIVE COMPARATORPatients receive 60mg of pioglitazone once a day orally for 9 days
2
PLACEBO COMPARATORPatients receive Placebo orally once a day for 9 days
Interventions
Eligibility Criteria
You may qualify if:
- Cirrhosis, grade B or C (Child-Pugh score)
You may not qualify if:
- History of hypersensitivity to the trial drugs and contrast agent or to drugs with a similar chemical structure
- Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systemic antibiotics one week before the study
- Cardiac, renal or respiratory failure
- Previous surgical or transjugular intrahepatic portosystemic shunt
- Insulin-dependent diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Internal Medicine III, Gastroenterology and Hepatology, Medical University of Vienna
Vienna, 1090, Austria
Related Publications (1)
Ferlitsch A, Pleiner J, Mittermayer F, Schaller G, Homoncik M, Peck-Radosavljevic M, Wolzt M. Vasoconstrictor hyporeactivity can be reversed by antioxidants in patients with advanced alcoholic cirrhosis of the liver and ascites. Crit Care Med. 2005 Sep;33(9):2028-33. doi: 10.1097/01.ccm.0000178173.27923.eb.
PMID: 16148476BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnulf Ferlitsch, MD
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 10, 2007
First Posted
December 11, 2007
Study Start
December 1, 2004
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
November 25, 2008
Record last verified: 2008-11