NCT06144086

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

November 16, 2023

Last Update Submit

April 24, 2026

Conditions

Liver Cirrhosis

Keywords

Liver CirrhosisHemophiliaHIV/HCV co-infection

Outcome Measures

Primary Outcomes (1)

  • ALBI score

    Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin \[mg/dL\] x 17.1) x 0.66 + (albumin \[g/dL\] x 10 x -0.085)

    Baseline to 24 weeks after administration

Secondary Outcomes (13)

  • Child-Pugh score

    Baseline to 12, 24 and 28 weeks after administration

  • ALBI score

    Baseline to 12 and 28 weeks after administration

  • Liver stiffness measurement by FibroScan

    Baseline to 12 and 24 weeks after administration

  • Serum fibrosis markers

    Baseline to 12 and 24 weeks after administration

  • Serum albumin

    Baseline to 12, 24 and 28 weeks after administration

  • +8 more secondary outcomes

Study Arms (1)

Foscenvivint

EXPERIMENTAL

Foscenvivint 280 mg/m2, twice a week for 24 weeks

Drug: Foscenvivint

Interventions

FoscenvivintDRUG

Administered by intravenous (IV) infusion over 3-4 hours

Also known as: CBP-beta-catenin inhibitor, OP-724, PRI-724 (former name)
Foscenvivint

Eligibility Criteria

Age18 Years - 74 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
  • 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.
  • Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
  • Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
  • 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.
  • Patients with Performance Status 0-2.

You may not qualify if:

  • Patients with liver cirrhosis of which cause is not HCV or unknown.
  • Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
  • Patients with complication or history of malignant tumor (within 3 years before registration).
  • Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
  • Patients with active AIDS-indicator disease that require treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-Ku, Tokyo, 113-8677, Japan

Location

MeSH Terms

Conditions

Liver CirrhosisHemophilia A

Interventions

ICG 001

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kiminori Kimura, MD

    Tokyo Metropolitan Komagome Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Department of Hepatology

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

May 8, 2024

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

JP(3)