Covert Hepatic EncephalopathyGELSECTANNCT05189834
GELSECTAN® and Covert Hepatic Encephalopathy
A study testing Gelsectan in people with Covert Hepatic Encephalopathy, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covert Hepatic Encephalopathy
- What is being tested?
- Gelsectan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 11 Mar 2022to 30 Jul 2022
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years.
- Liver cirrhosis defined by a previous liver biopsy or by clinical data.
- Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
- Adequately informed patients who grant their written consent to participate in the study.
Who cannot join
- Alternative neurological diagnosis.
- Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
- Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
- Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
- MELD score greater than 25 at the time of inclusion.
- Hospitalization for any reason.
Show all 19Show fewer
- Neurological or psychiatric comorbidity that makes the evaluation of hepatic encephalopathy difficult. This includes patients with mental illnesses (dementia, cerebrovascular disease with sequelae, Parkinson's disease, schizophrenia).
- Active digestive bleeding. Before inclusion, there must have been a 48-hour period without signs of bleeding.
- Patients with hypersensitivity or allergy to any of the components of GELSECTAN® (grape, pea).
- Clinical situations in which the administration of oral feeding is contraindicated.
- Active oncological processes, including hepatocarcinoma.
- Active infection of any origin.
- Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO group (Kidney Disease Improving Global Outcomes).
- Dehydration Diagnosed by physical examination of the patient.
- Severe hyponatremia. Defined by plasma sodium <130 mEq / dl.
- Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...)
- Active drug and/or alcohol use. In each case of clinical suspicion of drug use, an analysis of toxins in urine will be carried out, which includes cocaine, cannabis, opiates. All patients with confirmed alcohol consumption greater than 3 UBD in men or 2 UBD in women will be excluded.
- Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol and antibiotics.
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of GELSECTAN® Administration on Covert Hepatic Encephalopathy (CHE) in Patients With Cirrhosis.
Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged.
The objective of the trial is to obtain pilot variances to design a phase II trial, in which the efficacy of the treatment will be tested. As an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed.
Main endpoint Improvement in CHE after 30 days of treatment with GELSECTAN®, measured by the Psychometric hepatic encephalopathy score (PHES)
- Conditions
- Covert Hepatic Encephalopathy
- Being tested
- Gelsectan
- Keywords
- Covert Hepatic Encephalopathy, Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelsectanDietary supplement
Xyloglucan, vegetable protein and xylooligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence A | Other | Patients will follow the following treatment sequence:
1. Treatment with Gelsectan® (30 days)
2. Washout period (15 days)
3. Treatment with placebo (30 days) Receives: Dietary Supplement: Gelsectan |
| Treatment sequence B | Other | Patients will follow the following treatment sequence:
1. Treatment with placebo (30 days)
2. Washout period (15 days)
3. Treatment with Gelsectan® (30 days) Receives: Dietary Supplement: Gelsectan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Covert Hepatic Encephalopathy change
Covert Hepatic Encephalopathy change after 30 days of treatment with GELSECTAN®, by means of the Psychometric hepatic encephalopathy score (PHES), being patients classified as having MHE when their PHES is less than -4
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start11 Mar 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Why it stopped: The trial was not performed because logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covert Hepatic EncephalopathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189834
- Sponsor's protocol ID
- CSAPG-3
- Acronym
- GELSECTAN
- Status last verified
- Feb 2024
- First submitted
- 28 Dec 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GELSECTAN® Administration on Covert Hepatic Encephalopathy (CHE) in Patients With Cirrhosis.
- ClinicalTrials.gov ID
- NCT05189834
- Acronym / sponsor ID
- GELSECTAN / CSAPG-3
- Conditions
- Covert Hepatic Encephalopathy
- Keywords
- Covert Hepatic Encephalopathy, Cirrhosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was not performed because logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 11 Mar 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 13 Jan 2022 (actual)
- 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.
Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged.
The objective of the trial is to obtain pilot variances to design a phase II trial, in which the efficacy of the treatment will be tested. As an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed.
Main endpoint Improvement in CHE after 30 days of treatment with GELSECTAN®, measured by the Psychometric hepatic encephalopathy score (PHES)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence A | Other | Dietary Supplement: GelsectanPatients will follow the following treatment sequence: 1. Treatment with Gelsectan® (30 days) 2. Washout period (15 days) 3. Treatment with placebo (30 days) |
| Treatment sequence B | Other | Dietary Supplement: GelsectanPatients will follow the following treatment sequence: 1. Treatment with placebo (30 days) 2. Washout period (15 days) 3. Treatment with Gelsectan® (30 days) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 85 years.
- Liver cirrhosis defined by a previous liver biopsy or by clinical data.
- Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
- Adequately informed patients who grant their written consent to participate in the study.
Key exclusion criteria (19 listed)
- Alternative neurological diagnosis.
- Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
- Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
- Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
- MELD score greater than 25 at the time of inclusion.
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 |
|---|---|---|
| GelsectanXyloglucan, vegetable protein and xylooligosaccharides | Dietary supplement | Treatment sequence A, Treatment sequence B |
Primary outcome
Covert Hepatic Encephalopathy change
Time frame: 30 days
Covert Hepatic Encephalopathy change after 30 days of treatment with GELSECTAN®, by means of the Psychometric hepatic encephalopathy score (PHES), being patients classified as having MHE when their PHES is less than -4
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes
Related trials for Covert Hepatic Encephalopathy
Recruiting
Affect of Melatonin on Sleep and Cognition in Cirrhosis
Hepatic Encephalopathy, Covert Hepatic Encephalopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelsectan in people with Covert Hepatic Encephalopathy, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 19 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: withdrawn, as of the sponsor's last update on 28 Feb 2024. 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 Spain. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Covert Hepatic Encephalopathy change (time frame: 30 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 28 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.