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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05189834
Other study ID # CSAPG-3
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 11, 2022
Est. completion date July 30, 2022

Study information

Verified date February 2024
Source Consorci Sanitari de l'Alt Penedès i Garraf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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)


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Study Design


Intervention

Dietary Supplement:
Gelsectan
Xyloglucan, vegetable protein and xylooligosaccharides

Locations

Country Name City State
Spain Consorci Sanitari Alt'Pènedes i Garraf Barcelona Cataluña

Sponsors (1)

Lead Sponsor Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06367127 - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Completed NCT03077217 - Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy Phase 4
Completed NCT03585257 - HEAL STUDY (Hepatic Encephalopathy and Albumin Study) Phase 2