Preliminary Efficacy and Tolerability of NCX-1000 After Repeated Oral Doses in Patients With Elevated Portal Pressure
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|ClinicalTrials.gov Identifier: NCT00414869|
Recruitment Status : Terminated (Preliminary analysis of 11 patients did not demonstrate the efficacy required.)
First Posted : December 22, 2006
Last Update Posted : February 9, 2017
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 or disease||Intervention/treatment||Phase|
|Portal Hypertension||Drug: NCX-1000 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preliminary Efficacy And Tolerability Of Oral NCX-1000 After Repeated Administrations In Patients With Portal Hypertension: A Double-Blind Dose Escalating Study|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
Experimental drug under evaluation
500 mg powder sachets to be taken as 1, 2, or 4 sachets twice daily, PO x 16 days
Placebo Comparator: Placebo
Inactive powder matching NCX-1000
- 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. [ Time Frame: Day1 and Day 16 ]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
- Safety parameters: systolic and diastolic blood pressures, heart rate, physical examination, laboratory tests and Adverse Events (AEs) [ Time Frame: At various times ]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
- Plasma levels of NCX-1000 and its main metabolites will be evaluated to get preliminary pharmacokinetic data. [ Time Frame: 0, 1, 2, 3, and 4 hours after the first 3 doses anf after the last dose ]Usual pharmacokinetic (PK) evaluation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414869
|Hospital Clinic i Provincial de Barcelona|
|Barcelona, Spain, 08036|
|Principal Investigator:||Jaime Bosch, MD||Clinic Barcelona Hospital Universatiri|