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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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Brief summary is complete. Study is closed.

Conditions

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Portal Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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NCX-1000

Experimental drug under evaluation

Group Type EXPERIMENTAL

NCX-1000

Intervention Type DRUG

500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days

Placebo

Placebo powder

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive powder matching NCX-1000

Interventions

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NCX-1000

500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days

Intervention Type DRUG

Placebo

Inactive powder matching NCX-1000

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No