Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure

This study has been terminated.

( A preliminary analysis of 11 patients confirmed the safety profile of NCX-1000 but did not demonstrate the efficacy required. )

First Received: December 21, 2006 Last Updated: November 16, 2007 History of Changes

Sponsor:	Axcan Pharma
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00414869

Purpose

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.

Condition	Intervention	Phase
Portal Hypertension	Drug: NCX-1000	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: NCX-1000

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs)
Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data.

Enrollment:	11
Study Start Date:	November 2005
Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414869

Locations

Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036

Sponsors and Collaborators

Axcan Pharma

More Information

No publications provided

Study ID Numbers:	NCXDE05-02
Study First Received:	December 21, 2006
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00414869 History of Changes
Health Authority:	United States: Food and Drug Administration; Spain: Spanish Medicines and Healthcare Products Agency (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS)

Keywords provided by Axcan Pharma:

Liver
Portal pressure
Fibrosis
Nitric oxide

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Vascular Diseases

Cardiovascular Diseases
Hypertension, Portal
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010