Trial · NCT03827200
A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
NCT03827200, Phase 2, Terminated, Noorik Biopharmaceuticals AG
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis. Trials, record NCT03827200. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03827200
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Utility of Ambrisentan in Lowering Portal Pressure in Patients With Liver Cirrhosis
- NCT number
- NCT03827200
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Noorik Biopharmaceuticals AG
- Conditions
- Cirrhosis, Portal Hypertension, Ascites
- Interventions
- Ambrisentan
- First posted
- 2019-02-01
- Last updated
- 2021-02-26
- Other registries' IDs
- eudract:2018-002088-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change in Hepatic Vein Pressure Gradient (HVPG) from Baseline to Day 14 | 14 Days | 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 |
| Secondary | Change in 24-hour Urinary Sodium Volume (UNaV) | 48 hours | The change in 24-hour Urinary Sodium Volume (UNaV) will be calculated as the difference in 24-hour UNaV at Baseline and the 24-hour UNaV at Day 1 (after the first study drug administration). Urinary sodium volume collected in the 24 hours of baseline will be compared to the Urinary sodium volume collected in the 24 hours after the first dose of the drug. Collection of urine will be ongoing for 48 hours in total. |
| Secondary | Change in weight | 28 days | The change in weight will be calculated as the difference in weight at baseline and weight recorded throughout the study |
| Secondary | Change in abdominal girth | 28 days | The change in abdominal girth will be calculated as the difference in abdominal girth at baseline and abdominal girth recorded throughout the study |
| Secondary | Change in Model of End-Stage Liver Disease (MELD) score | 28 days | The change in MELD score will be calculated as the difference in MELD score at baseline and the MELD scores recorded throughout the study. The MELD score is calculated according to the following formula: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43 The MELD score provides an indication of the anticipated mortality observed in previous studies when subjects were followed for 3-months, according to the following ranges: 71.3% mortality if score is 40 points or more 52.6% mortality if score between 30-39 points 19.6% mortality if score between 20-29 points 6.0% mortality if score between 10-19 points 1.9% mortality if score 9 points or less The MELD score will be calculated at each visit during a 28 day period. |
| Secondary | Change in Child-Pugh score | 28 days | The change in Child-Pugh score will be calculated as the difference in Child-Pugh score at baseline and the Child-Pugh scores recorded throughout the study The Child-Pugh score provides information on the prognosis of a patient based on 5 clinical parameters which are individually graded. These parameters include laboratory values and other clinical information from the patient, such as the presence of ascites or hepatic encephalopathy. A lower score signifies a better chance and a higher score indicates a worse chance of survival at one year. Once the score is calculated it is further subclassified into three stages, depending on the score: Child A - the score is between 5 and 6. The survival rate is 100% Child B - the score is between 7 and 9. The survival rate is 80% Child C - the score is between 10 and 15. The survival rate is 45% |
| Secondary | Change in Cardiac Output | 14 days | The change in Cardiac Output will be calculated as the difference in Cardiac Output at baseline and the Cardiac Output recorded at Day 14 |
| Secondary | Change in Cardiac Index | 14 days | The change in Cardiac Index will be calculated as the difference in Cardiac Index at baseline and the Cardiac Index recorded at Day 14 |
| Secondary | Change in Pulmonary Capillary Wedge Pressure | 14 days | The change in Pulmonary Capillary Wedge Pressure will be calculated as the difference in Pulmonary Capillary Wedge Pressure at baseline and the Pulmonary Capillary Wedge Pressure recorded at Day 14 |
| Secondary | Change in Pulmonary Arterial Pressure | 14 days | The change in Pulmonary Arterial Pressure will be calculated as the difference in Pulmonary Arterial Pressure at baseline and the Pulmonary Arterial Pressure recorded at Day 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03827200
GET https://conductscience.org/api/trials/v1/NCT03827200/registered