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NCT Number: NCT06144086

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

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.

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Key information

Conditions

Liver Cirrhosis Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Fibrosis Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Hokkaido University Hospital, Sapporo, Hokkaido, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • 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.

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.

Treatment and study plan

Foscenvivint

Drug

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

Other names: CBP-beta-catenin inhibitor, OP-724, PRI-724 (former name)

Primary outcomes

  1. ALBI score

    Time frame: Baseline to 24 weeks after administration

    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)

Secondary outcomes

  1. Child-Pugh score

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Change from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration.

    Child-Pugh score is determined by scoring the following five clinical measures.

    Encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points

    Ascites: None = 1 point, slight = 2 points, moderate = 3 points

    Bilirubin: < 2 mg/dL = 1 point, 2 to 3 mg/dL = 2 points, > 3 mg/dL = 3 points

    Albumin: > 3.5 g/dL = 1 point, 2.8 to 3.5 g/dL = 2 points, < 2.8 g/dL = 3 points

    Prothrombin Time (%): > 70% = 1 point, 40 to 70% = 2 points, < 40% = 3 points

  2. ALBI score

    Time frame: Baseline to 12 and 28 weeks after administration

    Change from baseline in ALBI score at 12 and 28 weeks after administration.

  3. Liver stiffness measurement by FibroScan

    Time frame: Baseline to 12 and 24 weeks after administration

    Change from baseline in Liver stiffness measurement by FibroScan at 12 and 24 weeks after administration.

  4. Serum fibrosis markers

    Time frame: Baseline to 12 and 24 weeks after administration

    Change from baseline in Serum fibrosis markers at 12 and 24 weeks after administration.

  5. Serum albumin

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Change from baseline in serum albumin at 12, 24 and 28 weeks after administration.

  6. Serum bilirubin

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Change from baseline in serum bilirubin at 12, 24 and 28 weeks after administration.

  7. PT%

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Change from baseline in PT% at 12, 24 and 28 weeks after administration.

  8. MELD score

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Change from baseline in MELD score at 12, 24 and 28 weeks after administration.

    The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. The higher the score, the more serious the subject's disease. MELD is calculated according to the following formula:

    MELD score = 3.78 x ln(serum bilirubin [mg/dL]) + 11.2 x ln(PT-INR) + 9.57 x ln(serum creatinine [mg/dL]) + 6.43

  9. FIB-4 index

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Change from baseline in FIB-4 index at 12, 24 and 28 weeks after administration.

    FIB-4 index = (Age [years] x AST [U/L]) / (Platelet Count [10*9/L] x √ ALT [U/L] )

  10. mALBI grade

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Percentage of subjects who achieved >= 1 stage improvement in mALBI grade from baseline at 12, 24 and 28 weeks after administration.

    Based on ALBI score, mALBI grade is classified into Grade 1 to 3 shown below.

    mALBI grade: Grade 1: <=-2.60; Grade 2a: >-2.60 to <-2.27; Grade 2b: >=-2.27 to -1.39; Grade 3: >-1.39

  11. Achievement in Child-Pugh classification

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Percentage of subjects who changed from grade B at baseline to grade A at 12, 24 and 28 weeks after administration in Child-Pugh classification.

    Based on the total points in Child-Pugh score (scale range 5-15 points, the severity increases sequentially from 5 to 15 points), the severity of the disease is classified into Grade A to C shown below.

    Child-Pugh classification:

    Grade A: 5 to 6 points -> Compensated cirrhosis; Grade B: 7 to 9 points -> Decompensated cirrhosis; Grade C: 10 to 15 points -> Decompensated cirrhosis

  12. Achievement in Child-Pugh score

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Percentage of subjects who achieved >= 2 points improvement from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration.

  13. Achievement in Child-Pugh classification and score

    Time frame: Baseline to 12, 24 and 28 weeks after administration

    Percentage of subjects who changed from grade B to grade A in Child-Pugh classification and achieved >= 2 points improvement in Child-Pugh score from baseline at 12, 24 and 28 weeks after administration.

Sponsors and collaborators

Lead sponsor

Kiminori Kimura, MD

Other

Collaborators

  • Japan Agency for Medical Research and Development

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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