Cirrhotic Patients Undergoing TIPS PlacementPhase 1/2NCT02931123
A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY
A Phase 1/2 study testing lattulose and rifaximine in people with Cirrhotic Patients Undergoing TIPS Placement, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhotic Patients Undergoing TIPS Placement
- What is being tested?
- lattulose and rifaximine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to Nov 2018
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive cirrhotic patients undergoing TIPS
Who cannot join
- age >75 years; bilirubin levels >5 mg/dl; creatinine levels >3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score >11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score >18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state < 26).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Clinical Medicine
Rome, RM, 00100
Oliviero Riggio, Professor, +390649972021, oliviero.riggio@uniroma1.it
About this study
This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.
- Being tested
- lattulose and rifaximine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lattulose and rifaximineDrug
| Study group | Role | What they receive |
|---|---|---|
| standard | No intervention | Not described |
| treatment | Experimental | rifaximine and lattulose plus low proteine diet Receives: Drug: lattulose and rifaximine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hepatic encephalopathy
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhotic Patients Undergoing TIPS PlacementStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof oliviero Riggio, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931123
- Sponsor's protocol ID
- OR-201
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY
- ClinicalTrials.gov ID
- NCT02931123
- Acronym / sponsor ID
- OR-201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 12 Oct 2016 (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.
This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard | No intervention | – |
| treatment | Experimental | Drug: lattulose and rifaximinerifaximine and lattulose plus low proteine diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive cirrhotic patients undergoing TIPS
Key exclusion criteria (1 listed)
- age >75 years; bilirubin levels >5 mg/dl; creatinine levels >3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score >11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score >18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state < 26).
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 |
|---|---|---|
| lattulose and rifaximine | Drug | treatment |
Primary outcome
incidence of hepatic encephalopathy
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lattulose and rifaximine in people with Cirrhotic Patients Undergoing TIPS Placement, run by University of Roma La Sapienza at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 2016. 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 Italy. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliviero Riggio, Professor (+390649972021, oliviero.riggio@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hepatic encephalopathy (time frame: one month). 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 12 Oct 2016.