Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
Status and phase
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About
Chronic liver diseases are often characterized by portal hypertension, a major complication involving haemodynamic changes due to increased intrahepatic vascular resistance. It has become well established that nitric oxide (NO) plays a crucial role in the haemodynamic abnormalities that develop in chronic portal hypertension.
NCX-1000 is a NO-releasing derivative of ursodeoxycholic acid that would compensate for the defective liver NO production in cirrhosis.
This study intends to demonstrate the desired therapeutic activity (reduction in portal pressure) in a small number of target patients, to assess the safety and tolerability after repeated oral administrations of NCX-1000, and to get preliminary pharmacokinetic data in this population.
Full description
Brief summary is complete. Study is closed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or non-pregnant female patients of at least 18 years old
- HVPG > 12 mm Hg in fasting state on Day 1
- Free of any other condition (except liver failure) that may alter absorption, distribution, or elimination of drugs
Exclusion criteria
- Oesophageal bleeding in the previous 30 days
- Known intolerance to ursodeoxycholic acid or nitrates
- Liver cancer or liver metastasis from another cancer
- Portal hypertension secondary to venous thrombosis
- Presence of Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Severe liver failure (Child-Pugh C)
Trial design
Primary purpose
Allocation
Interventional model
Masking
11 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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