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NCT05189834: GELSECTAN

GELSECTAN® and Covert Hepatic Encephalopathy

Withdrawn NA Last updated 28 February 2024
What this trial tests

NA trial testing Gelsectan in Covert Hepatic Encephalopathy. Withdrawn.

Timeline
11 March 2022
Primary endpoint
30 May 2022
30 July 2022

Quick facts

Lead sponsorConsorci Sanitari de l'Alt Penedès i Garraf
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Start date11 March 2022
Primary completion30 May 2022
Estimated completion30 July 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Consorci Sanitari de l'Alt Penedès i Garraf — full company profile →

Who can join

Adults 18 to 85, any sex, with Covert Hepatic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Future Therapies of Hepatic Encephalopathy.
    Buckholz AP, Brown RS. · · 2024 · cited 5× · PMID 38548443 · DOI 10.1016/j.cld.2024.02.002

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Other trials of Gelsectan

Trials testing the same drug.

Other Consorci Sanitari de l'Alt Penedès i Garraf trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05189834.

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