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Refractory Ascites in Patients With Liver Cirrhosis, and the Potential Treatment With 48 Hours Infusion of Ularitide.

NCT04311489 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-05-18

No results posted yet for this study

Summary

This clinical trial intends to investigate the safety, tolerability and efficacy of ularitide on the renal response in patients with liver cirrhosis and refractory ascites for a maximum exposure duration of 48 hours, through a randomized, placebo-controlled, double-blind, single-center trial.

Conditions

  • Cirrhosis, Liver
  • Ascites Hepatic

Interventions

DRUG

Ularitide

Continuous intravenous infusion for 48 hours at a dose of 30 ng/kg/min. Depending on effect and/or side effects dose can be adjusted to 15 ng/kg/min or 45 ng/kg/min.

DRUG

Placebo

Continuous intravenous infusion for 48 hours at a bodyweight-adjusted infusion rate.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • ADS AIPHIA Development Services AG

    collaborator UNKNOWN

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Henning Grønbæk, Prof,MD,PhD · Department of Hepatology and Gastroenterology, Aarhus University Hospital,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311489 on ClinicalTrials.gov