CompletedPhase 2

A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia (OP-724-H201)

Japan5 participantsStarted 2024-05-08

Plain-language summary

This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.

Who can participate

Age range18 Years – 74 Years

SexMALE

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Inclusion criteria

✓. Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA \< 200 copies/mL and CD4 positive T lymphocyte count \>= 200 cells/µL at screening).
✓. Regarding HCV, patients who had passed \>= 12 months after achieving SVR at registration.
✓. Liver stiffness measurement by FibroScan is \>= 12.5 kPa (Fibrosis stage F4) at screening.
✓. Abdominal CT scan shows changes in liver shape and/or portal hypertension.

What they're measuring

ALBI score

Timeframe: Baseline to 24 weeks after administration

Trial details

NCT IDNCT06144086

SponsorKiminori Kimura, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-27

View on ClinicalTrials.gov More Liver Cirrhosis trials