AscitesPhase 3CATSNCT00358878
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)
A Phase 3 study testing Satavaptan in people with Ascites and Liver Cirrhosis, run by Sanofi at 21 sites in 21 countries.
Trial summary
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver. Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and… 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 463 participants
- Where
- 21 sitesin 21 countries
- Study dates
- Jul 2006to Dec 2008
- Phase
- Phase 3
- 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
- Participants with cirrhosis of the liver
- Participants with clinically evident ascites primarily managed by diet and/or diuretics
- Stable treatment of ascites for at least the previous 2 weeks without paracentesis
- Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.
Who cannot join
- Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
- Known hepatocellular carcinoma
- Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
- Participants previously exposed to satavaptan in the past 12 months
Trial locations and contacts
21 sites in 21 countries.
21 sites in 21 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford, Surrey
About this study
Official title: Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.
Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.
The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
- Conditions
- Ascites, Liver Cirrhosis
- Being tested
- Satavaptan, placebo
- Keywords
- Ascites, Liver Cirrhosis
- 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.
SatavaptanDrug
Also called SR121463B
oral administration once daily
placeboDrug
oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| Satavaptan | Experimental | Not described Receives: Drug: Satavaptan |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of ascites worsening
Measured: at week 12
Secondary outcomes (2)
Composite endpoint of ascites worsening
Measured: at week 24
Increase in ascites
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2008
- Study completionDec 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358878
- Sponsor's protocol ID
- EFC4492
- Other IDs
- EudraCT : 2006-000132-27, LTS10036
- Acronym
- CATS
- Status last verified
- Apr 2016
- First submitted
- 31 Jul 2006
- Last updated
- 26 May 2016
- Results posted
- No
Publications
Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines 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.
PubMed 21836029
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
- ClinicalTrials.gov ID
- NCT00358878
- Acronym / sponsor ID
- CATS / EFC4492
- Conditions
- Ascites, Liver Cirrhosis
- Keywords
- Ascites, Liver Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Aug 2006 (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.
Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.
Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.
The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Satavaptan | Experimental | Drug: Satavaptan |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with cirrhosis of the liver
- Participants with clinically evident ascites primarily managed by diet and/or diuretics
- Stable treatment of ascites for at least the previous 2 weeks without paracentesis
- Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.
Key exclusion criteria (4 listed)
- Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
- Known hepatocellular carcinoma
- Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
- Participants previously exposed to satavaptan in the past 12 months
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 |
|---|---|---|
| SatavaptanAlso: SR121463Boral administration once daily | Drug | Satavaptan |
| placebooral administration once daily | Drug | Placebo |
Primary outcome
Composite endpoint of ascites worsening
Time frame: at week 12
2 secondary outcomes
Composite endpoint of ascites worsening
Time frame: at week 24
Increase in ascites
Time frame: at week 12
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 26 May 2016.
- Derived from this study: PubMed 21836029Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines 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.
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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 study director
Sanofi
21 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Satavaptan in people with Ascites and Liver Cirrhosis, run by Sanofi at 21 sites in 21 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 4 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Argentina, Australia, Belgium, Brazil and 16 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Composite endpoint of ascites worsening (time frame: at week 12). 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 NCT00358878, 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 26 May 2016.