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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)

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05189834
Study type Interventional
Source Consorci Sanitari de l'Alt Penedès i Garraf
Contact Sonia Albertos, PhD
Phone 938 96 00 25
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 30, 2022
Completion date July 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT03077217 - Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy Phase 4
Recruiting NCT03585257 - HEAL STUDY (Hepatic Encephalopathy and Albumin Study) Phase 2