Study to see if N-003 has an effect in helping a patient with a very sick liver to remove water from the body, a common cause of accumulation of water in the abdomen. Also, the study will see which dose of N-003 is more effective as determined by using several different tests and to examine the safety and tolerability of N-003 in these patients.

Phase 1

• Conditions: Decompensated cirrhosis of the liver; MedDRA version: 19.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 19.0Level: LLTClassification code 10038448Term: Renal failure NOSSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002226-36-GR
• Lead Sponsor: oorik Biopharmaceuticals AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-16
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

•Signed informed consent including data protection declaration prior to study participation.
•Cirrhosis by biopsy and/or clinical/laboratory parameters.
•Paracentesis occurring between 7 and 30 days prior to baseline or patient is a candidate for Transjugular Intrahepatic Portosystemic Shunt (TIPS).
•Patient is on a stable regimen of diuretics for the last 15 days.
•Patient has a medical history of at least one previous paracentesis procedure being performed (total in medical history of at least two).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

•Age less than 18 or more than 75 years of age.
•INR >2.5x.
•Total bilirubin >= 6 mg/dL or 100 µmol/L.
•Serum sodium <120 meq/L.
•Serum creatinine >1.5 mg/dL (>132.6 µmol/L).
•Recent change in serum creatinine >0.3 mg/dL or 27 µmol/L in the last 60 days (increase or decrease).
•Presence of organic renal disease or secondary causes of renal dysfunction (proteinuria >500mg/day, active urinary sediment, history of abnormal renal ultrasound or recent use of nephrotoxic medications).
•Causes of ascites other than cirrhosis and portal hypertension.
•Cause of cirrhosis is primary biliary cirrhosis or patient has hepatocellular carcinoma beyond the Milan criteria.
•History of TIPS or surgical shunt.
•Variceal bleeding, encephalopathy (Grade II or more), bacterial infection (positive blood, urine or ascites culture - above 250 cells / mm3) within 2 weeks from enrolment.
•Clinical signs of congestive heart failure as determined by the investigator.
•Acute alcoholic hepatitis.
•In the investigator’s opinion, the patient is likely to die in the next 3 months.
•Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at the time of screening that in the judgment of the investigator would preclude safe completion of the study or constrains pharmacokinetic assessment.
•History of Portal thrombosis secondary to malignancy.
•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 pregnancy test at screening and baseline visits and must agree to use an effective contraceptive method (such as a hormonal contraceptive and barrier method) throughout the study.
•Presence of metabolites of illicit drugs in urine during screening procedures.
•Presence of a clinically significant anaemia, as judged by the Principal Investigator.
•Blood donation within 3 months prior to administration of the study medication.
•History of severe allergy or allergic reactions to the study drug or related drugs and products (including excipients of the formulation).
•Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
•Subjects who have difficulties in understanding the language in which the study information is given.
•Subjects who do not agree to the transmission of their anonymous data within the liability of documentation and notification.
•Staff of the study centre, staff of the sponsor or CRO, the investigator himself or close relatives of the investigator.
•Recent therapy with vasoactive drugs (octreotide, somatostatin, terlipressin, noradrenaline), antibiotics is not permitted except for antibiotics for the prevention of spontaneous bacterial peritonitis which are allowed throughout the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified