CirrhosisPhase 3NCT01556646
Effect of Tolvaptan on Cognitive Function in Cirrhosis
A Phase 3 study testing Tolvaptan in people with Cirrhosis and Hepatic Encephalopathy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Hepatic Encephalopathy, Hyponatremia
- What is being tested?
- Tolvaptan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count <150,000 with an AST/ALT ratio >1).
- History of HE controlled on lactulose and/or rifaximin
- Last HE episode >2 months prior to enrollment and <2 episodes within 6 months
- Mini-mental status exam score ≥25
- Serum sodium <130mg/dl within the last 14 days and the day of enrollment
- Availability of a caregiver
- Able to undergo MR of the head
Who cannot join
- Uncontrolled HE manifested by MMSE <25
- Alcohol abuse within 3 months
- Illicit drug use within 3 months
- Psychoactive drug use other than regularly scheduled anti-depressants or methadone.
- Contraindication to MR examination (see attached MRI Safety Form)
- Placement of a transjugular intra-hepatic portosystemic shunt (TIPS)
Show all 11Show fewer
- Creatinine Clearance less than 10 ml/min or undergoing hemodialysis
- HIV infection
- Use of azole medications
- Pregnancy
- Current use of tolvaptan, hypertonic saline or other medical therapies for hyponatremia
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
Official title: Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial
Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia
Read the detailed description
Baseline assessment will include a
- battery of eight cognitive tests
- Health related quality of life
- MRI head evaluating MR spectroscopy and diffusion tensor imaging
Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed.
Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between.
Participation will be terminated in case patients get transplanted or develop overt HE in between.
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Hyponatremia
- Being tested
- Tolvaptan
- Keywords
- Cirrhosis, Hepatic Encephalopathy, Hyponatremia, Brain MRI, Health-related quality of life, cognitive function
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
15 to 30mg qd titrated to sodium concentration
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan | Experimental | Open label study of tolvaptan. First 3 days as an inpatient then outpatient for the remainder of the study Receives: Drug: Tolvaptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance
Measured: 14 days
Secondary outcomes (3)
Brain MR Spectroscopy
Measured: 14 days
Brain Diffusion Tensor Imaging
Measured: 14 days
Health-related Quality of Life
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Principal investigator, Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Investigators
- Jasmohan S Bajaj, MD, Principal investigator, Hunter Holmes McGuire VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556646
- Sponsor's protocol ID
- Bajaj 01720
- Status last verified
- Feb 2014
- First submitted
- 15 Mar 2012
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tolvaptan on Cognitive Function, Brain Metabolism and Quality of Life in Hyponatremic Cirrhotics With Hepatic Encephalopathy: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01556646
- Acronym / sponsor ID
- Bajaj 01720
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Hyponatremia
- Keywords
- Cirrhosis, Hepatic Encephalopathy, Hyponatremia, Brain MRI, Health-related quality of life, cognitive function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Mar 2012 (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.
Hypothesis: Tolvaptan will improve cognitive function, brain edema and health-related quality of life in cirrhotic patients with hyponatremia
Detailed description
Baseline assessment will include a
- battery of eight cognitive tests
- Health related quality of life
- MRI head evaluating MR spectroscopy and diffusion tensor imaging
Patients will then be given tolvaptan 15-30mg qd for 14 days after which the tests will be repeated. During the first 3 days of tolvaptan administration, patients will be admitted and serum sodium will be drawn every 8 hours. 24 hr urine collection will also be performed.
Between the initiation and end of tolvaptan, patients will be seen at least every 3-5 days in between.
Participation will be terminated in case patients get transplanted or develop overt HE in between.
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: TolvaptanOpen label study of tolvaptan. First 3 days as an inpatient then outpatient for the remainder of the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cirrhosis diagnosed by liver biopsy or radiological evidence of nodular cirrhotic liver or varices on endoscopy or laboratory features (platelet count <150,000 with an AST/ALT ratio >1).
- History of HE controlled on lactulose and/or rifaximin
- Last HE episode >2 months prior to enrollment and <2 episodes within 6 months
- Mini-mental status exam score ≥25
- Serum sodium <130mg/dl within the last 14 days and the day of enrollment
Key exclusion criteria (11 listed)
- Uncontrolled HE manifested by MMSE <25
- Alcohol abuse within 3 months
- Illicit drug use within 3 months
- Psychoactive drug use other than regularly scheduled anti-depressants or methadone.
- Contraindication to MR examination (see attached MRI Safety Form)
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: Samsca15 to 30mg qd titrated to sodium concentration | Drug | Tolvaptan |
Primary outcome
Cognitive performance
Time frame: 14 days
3 secondary outcomes
Brain MR Spectroscopy
Time frame: 14 days
Brain Diffusion Tensor Imaging
Time frame: 14 days
Health-related Quality of Life
Time frame: 14 days
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 7 Feb 2014.
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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.
Jasmohan S Bajaj, MD principal investigator
Hunter Holmes McGuire VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tolvaptan in people with Cirrhosis and Hepatic Encephalopathy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center 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 7 inclusion and 11 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 7 Feb 2014. 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 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?
Cognitive performance (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2014.