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

Kiminori Kimura, MD

Status and phase: Active, not recruiting; Phase 2

Conditions: Liver Cirrhosis

Treatments: Drug: Foscenvivint

Study type: Interventional

Funder types: Other

Identifiers

NCT06144086

jRCT2031230461 (Other Identifier)

OP-724-H201

Details and patient eligibility

About

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.

Full description

This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration.

Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included.

Enrollment: 6 estimated patients

Sex: Male

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):

  1. 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).
  2. 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:

  1. Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.
  2. Abdominal CT scan shows changes in liver shape and/or portal hypertension.

• Patients with Performance Status 0-2.

Key Exclusion Criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Foscenvivint

Experimental group

Description:

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

Treatment:

Drug: Foscenvivint