CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
Terlipressin acetate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01640964
NCT01640964Phase 2Completed
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An Exploratory Study to Investigate the Haemodynamic Effects of Serelaxin (RLX030) in Patients With Compensated Cirrhosis and Portal Hypertension

Novartis Pharmaceuticals·interventional·Posted Jul 16, 2012·Updated Mar 15, 2016

In Brief

A Phase 2 clinical trial evaluating Terlipressin acetate and Serelaxin (RLX030) for Compensated Cirrhosis and Portal Hypertension. Completed, enrolled 47 participants across 1 site.

Detailed Summary

The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCompensated Cirrhosis and Portal Hypertension
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2012
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.0 years ago

Interventions

Terlipressin acetatedrug

IV bolus injection

Serelaxin (RLX030)drug

Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours