A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia (OP-724-H201)
- Registration Number
- NCT06144086
- Lead Sponsor
- Kiminori Kimura, MD
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Foscenvivint Foscenvivint Foscenvivint 280 mg/m2, twice a week for 24 weeks
- Primary Outcome Measures
Name Time Method ALBI score 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 Outcome Measures
Name Time Method PT% Baseline to 12, 24 and 28 weeks after administration Change from baseline in PT% at 12, 24 and 28 weeks after administration.
Child-Pugh score 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 pointsALBI score Baseline to 12 and 28 weeks after administration Change from baseline in ALBI score at 12 and 28 weeks after administration.
Achievement in Child-Pugh classification 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 cirrhosisAchievement in Child-Pugh score 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.
Liver stiffness measurement by FibroScan Baseline to 12 and 24 weeks after administration Change from baseline in Liver stiffness measurement by FibroScan at 12 and 24 weeks after administration.
Serum fibrosis markers Baseline to 12 and 24 weeks after administration Change from baseline in Serum fibrosis markers at 12 and 24 weeks after administration.
Serum albumin Baseline to 12, 24 and 28 weeks after administration Change from baseline in serum albumin at 12, 24 and 28 weeks after administration.
FIB-4 index 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 \[U/L\] )Achievement in Child-Pugh classification and score 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.
MELD score 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 \[mg/dL\]) + 6.43Serum bilirubin Baseline to 12, 24 and 28 weeks after administration Change from baseline in serum bilirubin at 12, 24 and 28 weeks after administration.
mALBI grade 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
Trial Locations
- Locations (3)
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Tokyo Metropolitan Komagome Hospital
🇯🇵Bunkyo-Ku, Tokyo, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan