Clinical trial NCT06144086: A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia (OP-724-H201)
Official title: A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis
Hemophilia
HIV/HCV co-infection
Lead sponsor: Komagome Hospital
Sponsor class: OTHER
Collaborators: name: Japan Agency for Medical Research and Development
First posted: 2023-11-22
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: ALBI score
timeFrame: Baseline to 24 weeks after administration
Secondary outcomes:
measure: Child-Pugh score
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: ALBI score
timeFrame: Baseline to 12 and 28 weeks after administration
measure: Liver stiffness measurement by FibroScan
timeFrame: Baseline to 12 and 24 weeks after administration
measure: Serum fibrosis markers
timeFrame: Baseline to 12 and 24 weeks after administration
measure: Serum albumin
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: Serum bilirubin
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: PT%
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: MELD score
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: FIB-4 index
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: mALBI grade
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: Achievement in Child-Pugh classification
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: Achievement in Child-Pugh score
timeFrame: Baseline to 12, 24 and 28 weeks after administration
measure: Achievement in Child-Pugh classification and score
timeFrame: Baseline to 12, 24 and 28 weeks after administration
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Bunkyo-Ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
state: Tokyo
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
Study officials:
affiliation: Tokyo Metropolitan Komagome Hospital
name: Kiminori Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References: