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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031230461 | Other Identifier | Japan Registry of Clinical Trials (jRCT) |
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| Name | Class |
|---|---|
| Japan Agency for Medical Research and Development | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foscenvivint | Experimental | Foscenvivint 280 mg/m2, twice a week for 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foscenvivint | Drug | Administered by intravenous (IV) infusion over 3-4 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Child-Pugh score | 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 |
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Key Inclusion Criteria
Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
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:
Patients with Performance Status 0-2.
Key Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kiminori Kimura, MD | Tokyo Metropolitan Komagome Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan | ||
| National Hospital Organization Osaka National Hospital |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C492448 | ICG 001 |
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| Baseline to 12, 24 and 28 weeks after administration |
| ALBI score | Change from baseline in ALBI score at 12 and 28 weeks after administration. | Baseline to 12 and 28 weeks after administration |
| Liver stiffness measurement by FibroScan | Change from baseline in Liver stiffness measurement by FibroScan at 12 and 24 weeks after administration. | Baseline to 12 and 24 weeks after administration |
| Serum fibrosis markers | Change from baseline in Serum fibrosis markers at 12 and 24 weeks after administration. | Baseline to 12 and 24 weeks after administration |
| Serum albumin | Change from baseline in serum albumin at 12, 24 and 28 weeks after administration. | Baseline to 12, 24 and 28 weeks after administration |
| Serum bilirubin | Change from baseline in serum bilirubin at 12, 24 and 28 weeks after administration. | Baseline to 12, 24 and 28 weeks after administration |
| PT% | Change from baseline in PT% at 12, 24 and 28 weeks after administration. | Baseline to 12, 24 and 28 weeks after administration |
| MELD score | 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 | Baseline to 12, 24 and 28 weeks after administration |
| FIB-4 index | 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] ) | Baseline to 12, 24 and 28 weeks after administration |
| mALBI grade | 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 | Baseline to 12, 24 and 28 weeks after administration |
| Achievement in Child-Pugh classification | 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 | Baseline to 12, 24 and 28 weeks after administration |
| Achievement in Child-Pugh score | Percentage of subjects who achieved >= 2 points improvement from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration. | Baseline to 12, 24 and 28 weeks after administration |
| Achievement in Child-Pugh classification and score | 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. | Baseline to 12, 24 and 28 weeks after administration |
| Osaka |
| Osaka |
| 540-0006 |
| Japan |
| Tokyo Metropolitan Komagome Hospital | Bunkyo-Ku | Tokyo | 113-8677 | Japan |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |