A Study of Terlipressin in Patients With Hepatorenal Synd... | NCT01373606

Studies
A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

NCT01373606

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Feb 14, 2012Estimated

Enrollment

8Actual

Phase

Phase 1Phase 2

Conditions

Hepatorenal Syndrome Type 1

Interventions

Terlipressin

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 10, 2011

First Submission Date that Met QC Criteria

Jun 14, 2011

First Posted Date

Jun 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2012

Last Update Posted Date

Feb 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
Terlipressin	Experimental		Drug: Terlipressin

Name	Type	Description	Arm Group Labels	Other Names
Terlipressin	Drug		Terlipressin

Measure	Description	Time Frame
Change in SCr value from baseline to end of treatment		16 days

Measure	Description	Time Frame
Incidence of adverse events and its severity		Up to 84 days
Laboratory test values		Up to 84 days
Vital signs

Eligibility Module

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]

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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site		Kansai			Japan
Investigational site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22038555	Background	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.

ID	Term
D008236	Lypressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones