Portal Hypertension Clinical Trial
Official title:
Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study
Verified date | February 2017 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Hepatic Venous Pressure Gradient (HVPG) will be evaluated at entry (Day 1) and after the Maximal Tolerated Dose (MTD) on Day 16, in fasting and post-prandial (after a standardized liquid breakfast) states. | The portal pressure, as determined by HVPG, was obtained by subtracting the free hepatic venous pressure from the wedged hepatic venous pressure and rounded to the nearest 0.5 or integer value.The pressures were recorded 3 times for each evaluation and the HVPG value was the mean of the 3 Recordings | Day1 and Day 16 | |
Secondary | Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs) | Usual safety parameters. Blood pressures were assessed every 30 minutes for 4 hours after drug intake. Other parameters were assessed or reported at Study visits | At various times | |
Secondary | Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data. | Usual pharmacokinetic (PK) evaluation | 0, 1, 2, 3, and 4 hours after the first 3 doses anf after the last dose |
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