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OP-724-002 study

A multi-center, placebo-controlled, randomized, double-blind phase 2 trial of foscenvivint in patients with decompensated cirrhosis related with HCV, HBV, or NASH

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230195
Enrollment
93
Registered
2023-07-01
Start date
2023-10-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated cirrhosis related with HCV, HBV or NASH Decompensated cirrhosis, HCV, HBV, NASH

Interventions

Cohort A (HCV, HBV) : - foscenvivint iv. twice a week - foscenvivint iv. once a week and placebo iv. once a week - Placebo iv. twice a week Cohort B (NASH) : - foscenvivint iv. twice a week - Plac
D060449
CBP/beta-catenin inhibitor

Sponsors

Sasaki Noriyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with decompansated cirrhosis (Child-Pugh class B: Score 7-9) 2. Patients with liver cirrhosis related with HCV, HBV, or NASH 3. Patients with performance Status: 0-2 4. Patients with serum albumin levels =<3.5 g/dL

Exclusion criteria

Exclusion criteria: 1. Patients with decompansated cirrhosis of which cause is unknown 2. Patients with refractory ascites 3. Patients with complication or history of malignant tumor (within 3 years before screening, excepting the patients with no relapse of hepatocellular carcinoma during more than 1 year from surgical treatment etc.)

Design outcomes

Primary

MeasureTime frame
Child-Pugh score

Secondary

MeasureTime frame
Child-Pugh score, ALBI score, Liver stiffness, Serum fibrosis markers, etc.

Contacts

Public ContactDepartment of Clinical Development

Ohara pharmaceutical Co., Ltd.

chiken@ohara-ch.co.jp+81-3-6740-7701

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026