Study Stopped
Lack of recruitment, result of COVID-19 pandemic
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
A Phase II, Single-arm, Open-label Study to Characterise the Effect on Portal Pressure, the Effect on Renal Function and the Pharmacokinetic Profile of N-003 in Patients With Decompensated Cirrhosis
2 other identifiers
interventional
19
1 country
6
Brief Summary
Endothelin is a human hormone which has been associated with increased portal pressure in patients with liver cirrhosis (also called portal hypertension). Ambrisentan blocks the effects of endothelin. The purpose of this study is to evaluate the effect of ambrisentan on portal pressure and renal function in patients with advanced liver cirrhosis and with portal hypertension. In this study, portal pressure will be determined at multiple times with the aid of a catheter inserted into the body of the patient. The effect of ambrisentan on the function of the kidney will also be investigated. This study will also evaluate the concentrations of ambrisentan in blood in patients with liver cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2021
CompletedFebruary 26, 2021
February 1, 2021
1.7 years
January 25, 2019
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change in Hepatic Vein Pressure Gradient (HVPG) from Baseline to Day 14
Baseline HVPG is defined as the HVPG assessment performed prior to the first study drug administration. Day 14 HVPG is defined as the HVPG assessment prior to the last dose of study drug. The mean change in HVPG will be calculated as the difference between the HVPG assessment performed at Day 14 and the HVPG assessment performed at baseline
14 Days
Secondary Outcomes (10)
Change in 24-hour Urinary Sodium Volume (UNaV)
48 hours
Change in weight
28 days
Change in abdominal girth
28 days
Change in Model of End-Stage Liver Disease (MELD) score
28 days
Change in Child-Pugh score
28 days
- +5 more secondary outcomes
Other Outcomes (4)
Proportion of patients achieving a 20% reduction in HVPG at Day 14 from baseline
14 days
Proportion of patients achieving a 10% reduction in HVPG at Day 14 from baseline
14 days
Proportion of patients achieving an HVPG of 10 mmHg or less at Day 14 from baseline
14 days
- +1 more other outcomes
Study Arms (1)
Ambrisentan
EXPERIMENTALAmbrisentan
Interventions
Ambrisentan will be administered subcutaneously at the Hospital on the days of HVPG deterination and taken orally at home between visits.
Eligibility Criteria
You may qualify if:
- Signed informed consent including data protection declaration prior to study participation
- Subjects with confirmed cirrhosis (by biopsy, ultrasound, and/or laboratory examinations)
- Ascites Grade II or Grade III at screening currently treated with at least one diuretic or the subject is considered intolerant to diuretics in the investigator's opinion
You may not qualify if:
- Age \<18 years of age
- Any of the following laboratory findings at the time of screening
- Serum creatinine level \>1.5mg/dL (\>132 µmol/L)
- Serum Na+ \< 125 meq/L
- Serum K+ ≥ 5.5 meq/L
- Serum bilirubin ≥ 5 mg/dL (85.5 µmol/L)
- INR \>3.0
- Women of childbearing potential with no effective contraceptive method (women of childbearing potential \[pre-menopausal, not surgically sterile for at least 3 months prior to the time of screening\] must have a confirmed negative serum β-hCG pregnancy test prior to enrolment and at Baseline Visit. They must use an effective contraceptive method throughout the study, and agree to repeat serum β-hCG pregnancy tests at designated visits)
- Pregnancy or lactation
- Systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg
- Sepsis and/or uncontrolled bacterial infection
- Current or recent documented nephrotoxicity (within 4 weeks)
- Hepatic Encephalopathy above grade 1
- History of variceal bleeding in the last 2 months
- Suspicion of active alcohol consumption in the last 3 months
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital Clinic Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, 28222, Spain
Vall d'Hebron University Hospital
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2019
First Posted
February 1, 2019
Study Start
April 11, 2019
Primary Completion
December 29, 2020
Study Completion
January 21, 2021
Last Updated
February 26, 2021
Record last verified: 2021-02