AscitesPhase 4NCT01292304

Tolvaptan for Ascites in Cirrhotic Patients

A Phase 4 study testing Tolvaptan in people with Ascites and Cirrhosis, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Ascites, Cirrhosis
What is being tested?: Tolvaptan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Jan 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
Clinically evident ascites treated by diet and/or diuretics
History of 1 or more therapeutic paracentesis in the previous 6 months.

Who cannot join

History of variceal bleeding
Current or history of Gastrointestinal bleeding within 10 days of screening
Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
INR (International normalized ratio) > 3.0, neutrophils <1500 cell/μl, platelets < 40,000/μl
serum bilirubin > 3 mg/dl
serum sodium < 125 meQ (milliequivalent)/L
serum potassium <3.5 meQ/L

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Hepatology
Gainesville, Florida, 32610-0277

Other trials in United States

About this study

Official title: Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

Read the detailed description

This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.

Conditions: Ascites, Cirrhosis
Being tested: Tolvaptan
Keywords: Cirrhotic, Tolvaptan, v2 receptor antagonist
Medical subject headings: Ascites, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TolvaptanDrug
Also called (SAMSCA)
Oral administration once daily Dosage will range from 15 mg to 30 mg

Study groups in NCT01292304
Study group	Role	What they receive
Tolvaptan	Experimental	Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability Receives: Drug: Tolvaptan

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing
Measured: Week 12
Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)
This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)
Measured: 12 weeks of study drug

Secondary outcomes (3)

Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)
Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing
Measured: 12 weeks
Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)
Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L
Measured: 12 weeks
Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)
This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.
Measured: 12 weeks of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jan 2015

First posted9 Feb 2011 (estimated)
Study startMar 2012
Primary completionDec 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AscitesStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01292304
Sponsor's protocol ID: 156-IST-10-06
Status last verified: Jun 2015
First submitted: 7 Feb 2011
Last updated: 27 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
RecruitingPhase 1/2
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
STOMACH NEOPLASM, Gastric Cancer
RecruitingPhase 2
High Dose Albumin in Refractory Ascites
Ascites
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites

All Ascites trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites
ClinicalTrials.gov ID: NCT01292304
Acronym / sponsor ID: 156-IST-10-06
Conditions: Ascites, Cirrhosis
Keywords: Cirrhotic, Tolvaptan, v2 receptor antagonist
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Otsuka America Pharmaceutical
Study start: Mar 2012
Primary completion: Dec 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 9 Feb 2011 (estimated)
Results: Posted 27 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tolvaptan	Experimental	Drug: TolvaptanTolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
Clinically evident ascites treated by diet and/or diuretics
History of 1 or more therapeutic paracentesis in the previous 6 months.

Key exclusion criteria (7 listed)

History of variceal bleeding
Current or history of Gastrointestinal bleeding within 10 days of screening
Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
INR (International normalized ratio) > 3.0, neutrophils <1500 cell/μl, platelets < 40,000/μl
serum bilirubin > 3 mg/dl

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
TolvaptanAlso: (SAMSCA)Oral administration once daily Dosage will range from 15 mg to 30 mg	Drug	Tolvaptan

Primary outcome

Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)
Time frame: Week 12
Increase in number of therapeutic paracentesis (removal of > 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing
Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)
Time frame: 12 weeks of study drug
This outcome will provide the number of subjects with a weight increase of > 2kg from baseline (worsening ascites)

3 secondary outcomes

Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)
Time frame: 12 weeks
Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)
Time frame: 12 weeks
Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)
Time frame: 12 weeks of study drug

Results and safety

Results posted to the registry on 27 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tolvaptan	10	10

Primary outcome: Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)

Time frame: Week 12. Number. Unit: participants

Measure	Tolvaptan n = 10
Value	0

Primary outcome: Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)

Time frame: 12 weeks of study drug. Number. Unit: participants

Measure	Tolvaptan n = 10
Value	7

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected from baseline day 1 of study drug through day 99 (2 weeks after last dose). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tolvaptan	1 of 10 (10%)	9 of 10 (90%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ascites

Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
RecruitingPhase 1/2
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
STOMACH NEOPLASM, Gastric Cancer
RecruitingPhase 2
High Dose Albumin in Refractory Ascites
Ascites
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites

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.

Giuseppe (Joseph) Morelli, MD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tolvaptan in people with Ascites and Cirrhosis, run by University of Florida at 1 site in United States.

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 3 inclusion and 7 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT01292304.

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 27 Jul 2015.