GELSECTAN® and Covert Hepatic Encephalopathy

NCT05189834 | Withdrawn

• 1 other identifier: CSAPG-3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Covert Hepatic Encephalopathy; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Study Arms (2)

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)

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)

Dietary Supplement: Gelsectan

Interventions

Gelsectan DIETARY_SUPPLEMENT

Xyloglucan, vegetable protein and xylooligosaccharides

Treatment sequence A; Treatment sequence B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Hospitalization for any reason.
• 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).
• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, 08810, Spain

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 13, 2022
• Study Start: March 11, 2022
• Primary Completion: May 30, 2022
• Study Completion: July 30, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (1)