NCT01373606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

June 10, 2011

Last Update Submit

February 13, 2012

Conditions

Hepatorenal Syndrome Type 1

Outcome Measures

Primary Outcomes (1)

  • Change in SCr value from baseline to end of treatment

    16 days

Secondary Outcomes (10)

  • Incidence of adverse events and its severity

    Up to 84 days

  • Laboratory test values

    Up to 84 days

  • Vital signs

    16 days

  • ECG

    Day 1,4,7,10,13,16

  • The percentage of patients with Hepatorenal syndrome reversal (SCr value <=1.5 mg/dL)

    16 days

  • +5 more secondary outcomes

Study Arms (1)

Terlipressin

EXPERIMENTAL
Drug: Terlipressin

Interventions

TerlipressinDRUG
Terlipressin

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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:
  • \[Modified International Ascites Club's Diagnostic criteria of HRS\]
  • Chronic or acute liver disease with advanced hepatic failure and portal hypertension.
  • Low glomerular filtration rate (SCr \>1.5 mg/dL or 24h Ccr \<40 mL/min)
  • Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug
  • 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.
  • Protein urea \<500 mg/dL, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease
  • Age; 20 to 79 years

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational site

Kansai, Japan

Location

Investigational site

Kanto, Japan

Location

Related Publications (1)

  • 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.

    PMID: 22038555BACKGROUND

MeSH Terms

Interventions

Terlipressin

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 15, 2011

Study Start

November 1, 2007

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

JP(2)