Genkyotex - Phase 2 Clinical Trial
Condividi questa pagina

Latest News

The PBC Foundation is the only UK based organisation that specifically deals with PBC.

Genkyotex - Phase 2 Clinical Trial

Genkyotex - Phase 2 Clinical Trial

“Genkyotex Initiates Patient Enrolment into Phase 2 Clinical Trial in Primary Biliary Cholangitis”

 

Genkyotex has begun enrolling patients into the Company’s Phase 2 clinical trial of its NOX1 and NOX4 enzymes inhibitor, in Primary Biliary Cholangitis (PBC). The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with PBC who are taking a stable dose of Ursodeoxycholic acid treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).

This research is looking into whether the study drug is better than a dummy drug when given to patients with PBC. This trial will monitor the patients taking part with regular blood tests and ultrasound liver scans before, during, and at the end of the trial. These measures will allow for the ongoing assessment of liver function, and liver stiffness. It is hoped that in patients for whom the study drug is beneficial, the liver dysfunction or stiffness may progress at a slower pace, or may even improve during or at the end of the trial. Participants will be randomly assigned to 1 of 3 treatment groups (active drug once daily, active drug twice daily or placebo). This is a double-blinded study so neither the participants nor the staff responsible for their care will know which group they have been assigned to. During the treatment period, participants will take 4 capsules orally at home in the morning and 4 capsules in the evening for 24 weeks.

Participants will be in the trial for 32 weeks in total (about 8 months) and will attend approximately 8 clinic visits.

The trial is being conducted in Belgium, Canada, Germany, Greece, Israel, Italy, Spain, United Kingdom, and the United States.

More details about the trial can be found at:

https://clinicaltrials.gov/ct2/show/NCT03226067?term=GENKYOTEX&rank=2

 

Press releases:

https://www.genkyotex.com/images/PDF/GB/1_Press_Releases/2017/PR_Genkyotex_Initiation_Ph2_Trial_PBC.pdf