GELSECTAN® and Covert Hepatic Encephalopathy

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Brief Title

GELSECTAN® and Covert Hepatic Encephalopathy

Official Title

Effects of GELSECTAN® Administration on Covert Hepatic Encephalopathy (CHE) in Patients With Cirrhosis.

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)
    



Study Type

Interventional


Primary Outcome

CHE improvement


Condition

Covert Hepatic Encephalopathy

Intervention

Gelsectan

Study Arms / Comparison Groups

 Treatment sequence A
Description:  Patients will follow the following treatment sequence:
Treatment with Gelsectan® (30 days)
Washout period (15 days)
Treatment with placebo (30 days)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

10

Start Date

January 30, 2022

Completion Date

July 30, 2022

Primary Completion Date

May 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Age between 18 and 85 years.

          2. Liver cirrhosis defined by a previous liver biopsy or by clinical data.

          3. Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods
             (PHES and / or S-ANT and / or Sloop-test).

          4. Adequately informed patients who grant their written consent to participate in the
             study.

        Exclusion Criteria:

          1. Alternative neurological diagnosis.

          2. Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.

          3. Terminal disease. At the discretion of the doctor, where the patient is in an
             irreversible situation, in which hepatic encephalopathy is a final manifestation.

          4. Presence of Acute-on-chronic liver failure defined by the presence of decompensated
             liver cirrhosis with severe organ or multi-organ failure.

          5. MELD score greater than 25 at the time of inclusion.

          6. Hospitalization for any reason.

          7. 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).

          8. Active digestive bleeding. Before inclusion, there must have been a 48-hour period
             without signs of bleeding.

          9. Patients with hypersensitivity or allergy to any of the components of GELSECTAN®
             (grape, pea).

         10. Clinical situations in which the administration of oral feeding is contraindicated.

         11. Active oncological processes, including hepatocarcinoma.

         12. Active infection of any origin.

         13. Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO
             group (Kidney Disease Improving Global Outcomes).

         14. Dehydration Diagnosed by physical examination of the patient.

         15. Severe hyponatremia. Defined by plasma sodium <130 mEq / dl.

         16. Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives
             (methadone, tramadol ...)

         17. 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.

         18. Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol
             and antibiotics.

         19. Participation in another clinical trial
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

, 938 96 00 25, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT05189834

Organization ID

CSAPG-3


Responsible Party

Sponsor

Study Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf


Study Sponsor

, , 


Verification Date

December 2021