A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

NCT ID: NCT01373606

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-12-31

Brief Summary

This is an open-label, multi-center study, investigating the efficacy and safety of terlipressin in Japanese patients with hepatorenal syndrome type 1.

Conditions

Hepatorenal Syndrome Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terlipressin

Group Type: EXPERIMENTAL

Terlipressin

Intervention Type: DRUG

Interventions

Terlipressin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who were diagnosed with HRS type 1 according to the diagnostic criteria of HRS and whose serum creatinine value (SCr) doubled at 2.5 mg/dL or greater within 2 weeks or whose 24h creatinine clearance (Ccr) decreased by half at less than 20 mL/min.

Patients should meet all the following 5 criteria:

[Modified International Ascites Club's Diagnostic criteria of HRS]

1. Chronic or acute liver disease with advanced hepatic failure and portal hypertension.

2. Low glomerular filtration rate (SCr >1.5 mg/dL or 24h Ccr <40 mL/min)

3. Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug

4. No sustained improvement in renal function (decrease in SCr to 1.5 mg/dL or less or increase in 24h Ccr to 40 mL/min or more) following diuretic withdrawal and expansion of plasma volume with 1,500 mL/24h of isotonic saline for 24 to 48h.

5. Protein urea <500 mg/dL, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease

• Age; 20 to 79 years

Exclusion Criteria

• Cr value ≥5 mg/dL
• Child-Pugh Score ≥14
• Fulminant hepatitis
• Septic shock
• Hepatocellular carcinoma that does not meet the Milan Criteria
• Acute renal failure caused by contrast medium
• Chronic renal failure
• Bradycardia (heart rate <50/min)
• Hyponatraemia (serum Na <120 mEq/L)
• Ischemic heart diseases (angina pectoris, myocardial infarction), heart failure or clinically relevant arrhythmia
• Poor-controlled hypertension
• Arteriosclerosis obliterans or peripheral vascular disorder
• Cerebrovascular disorder
• Respiratory diseases such as chronic obstructive pulmonary disease
• Pregnant or possibly pregnant women and patients who or whose partner desire -pregnancy during the study period
• Patients considered by the investigator or sub-investigator as unsuitable to participate in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Investigational site

Kansai, , Japan

Investigational site

Kanto, , Japan

Countries

Japan

References

Narahara Y, Kanazawa H, Sakamoto C, Maruyama H, Yokosuka O, Mochida S, Uemura M, Fukui H, Sumino Y, Matsuzaki Y, Masaki N, Kokubu S, Okita K. The efficacy and safety of terlipressin and albumin in patients with type 1 hepatorenal syndrome: a multicenter, open-label, explorative study. J Gastroenterol. 2012 Mar;47(3):313-20. doi: 10.1007/s00535-011-0485-8. Epub 2011 Oct 25.

Reference Type: BACKGROUND

PMID: 22038555 (View on PubMed)

Other Identifiers

FE999908 CS01

Identifier Type: -

Identifier Source: org_study_id