AscitesPhase 2SPANCT00501384
Satavaptan Dose-Ranging Study in the Prevention of Ascites
A Phase 2 study testing satavaptan (SR121463B) in people with Ascites and Liver Cirrhosis, run by Sanofi at 11 sites in 11 countries.
Trial summary
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Liver Cirrhosis
- What is being tested?
- satavaptan (SR121463B)
- How many people
- 151 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Apr 2004to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
- Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
- Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.
This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).
- Conditions
- Ascites, Liver Cirrhosis
- Being tested
- satavaptan (SR121463B)
- Keywords
- cirrhotic ascites
- Medical subject headings
- Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
satavaptan (SR121463B)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to repeat therapeutic paracentesis
Measured: 12 weeks
Secondary outcomes (3)
Increase in ascites judged by body weight and ascites volume
Measured: within 12 weeks
frequency of paracentesis
Measured: 12 weeks
quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startApr 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501384
- Sponsor's protocol ID
- DFI4522
- Other IDs
- LTS5635, LTS10209
- Acronym
- SPA
- Status last verified
- Jan 2009
- First submitted
- 13 Jul 2007
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wong F, Gines P, Watson H, Horsmans Y, Angeli P, Gow P, Minini P, Bernardi M. Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis. J Hepatol. 2010 Aug;53(2):283-90. doi: 10.1016/j.jhep.2010.02.036. Epub 2010 May 24.
PubMed 20541828
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites
- ClinicalTrials.gov ID
- NCT00501384
- Acronym / sponsor ID
- SPA / DFI4522
- Conditions
- Ascites, Liver Cirrhosis
- Keywords
- cirrhotic ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.
The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.
This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence
- Patients having undergone therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of ≥4 L of fluid
- Patients having undergone at least 1 other therapeutic paracentesis in the previous 3 months
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| satavaptan (SR121463B) | Drug | – |
Primary outcome
Time to repeat therapeutic paracentesis
Time frame: 12 weeks
3 secondary outcomes
Increase in ascites judged by body weight and ascites volume
Time frame: within 12 weeks
frequency of paracentesis
Time frame: 12 weeks
quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
- Derived from this study: PubMed 20541828Wong F, Gines P, Watson H, Horsmans Y, Angeli P, Gow P, Minini P, Bernardi M. Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis. J Hepatol. 2010 Aug;53(2):283-90. doi: 10.1016/j.jhep.2010.02.036. Epub 2010 May 24.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing satavaptan (SR121463B) in people with Ascites and Liver Cirrhosis, run by Sanofi at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Argentina, Australia, Belgium, Canada, Croatia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to repeat therapeutic paracentesis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2009; AzTrials last refreshed its copy on 6 Nov 2026.