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Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver (SPARe-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00366795
Recruitment Status : Terminated (Study was terminated due to safety reason.)
First Posted : August 21, 2006
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE August 18, 2006
First Posted Date  ICMJE August 21, 2006
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE August 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Number and time of recurrences of therapeutic paracenteses [ Time Frame: up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
Number and time of recurrences of therapeutic paracenteses up to 12 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
  • Time from randomisation to first recurrence of ascites [ Time Frame: study period ]
  • Increase in ascites [ Time Frame: over 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
  • Time from randomisation to first recurrence of ascites
  • Increase in ascites over 12 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Satavaptan for the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver
Official Title  ICMJE Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Brief Summary

Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ascites
  • Liver Cirrhosis
Intervention  ICMJE
  • Drug: Satavaptan
    oral administration once daily
    Other Name: SR121463B
  • Drug: placebo
    oral administration once daily
Study Arms  ICMJE
  • Experimental: Satavaptan
    Intervention: Drug: Satavaptan
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Ginès P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 17, 2009)
241
Original Enrollment  ICMJE
 (submitted: August 18, 2006)
450
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with cirrhosis of the liver.
  • Patients resistant to the effects of diuretics, intolerant of diuretics or otherwise unsuitable for treatment with diuretics according to the judgement of the investigator.
  • Patients with recurrent ascites having undergone both of the following:

    • therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of = or > 4 litres of fluid.
    • at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

  • Patients with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
  • Known hepatocellular carcinoma.
  • Patients with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
  • Patients previously exposed to satavaptan in the past 12 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   France,   Germany,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Singapore,   Spain,   Turkey,   United States
Removed Location Countries Former Serbia and Montenegro,   Hungary,   Israel,   Slovakia,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00366795
Other Study ID Numbers  ICMJE EFC6682
EudraCT : 2006-000132-27
LTS10036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP