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The purpose of this study is to explore whether silibinin plus ribavirin with/without peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C: RIB + Peg-IFN | Active Comparator | Ribavirin(800-1400 mg/day,divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC)for 25 weeks if RVR has been achieved or 49 weeks if EVR has been achieved |
|
| Group B:Legalon® SIL + RIB + Peg-IFN | Experimental | Silibinin (20 mg/Kg/day) for 6 days, followed by Silibinin + ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) for 15 days, followed by ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) + 2 days of Silibinin per week for 9 weeks, followed by ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) for 13 weeks if RVR has been achieved (for a total of 25 weeks of treatment) or 37 weeks if EVR has been achieved (for a total of 49 weeks of treatment) |
|
| Group A: Legalon® SIL + RIB | Experimental | Silibinin (20 mg/Kg/day) for 6 days, followed by Silibinin + ribavirin (800-1400 mg/day, divided BID PO) for 15 days, followed by ribavirin (800-1400 mg/day, divided BID PO) + 2 days of Silibinin per week for 9 weeks, followed by ribavirin (800-1400 mg/day, divided BID PO) for 13 weeks if RVR has been achieved (for a total of 25 weeks of treatment) or 37 weeks if EVR has been achieved (for a total of 49 weeks of treatment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Legalon® SIL (Silibinin) | Drug | Silibinin 20 mg/Kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment | The primary efficacy endpoint is the proportion of patients with Sustained Virological Response (SVR), i.e. undetectable HCV-RNA level lasting for 24 weeks after the completion of the study treatment course. | 24 weeks after the end of treatment (e.g. at week 49 or 73) |
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HCV-RNA | Proportion of patients with Rapid Viral Response (RVR), i.e. undetectable HCV-RNA levels 4 weeks after the beginning of the study treatment course. | 4 weeks after the beginning of the study treatment |
| HCV-RNA decrease ≥ 2 log10 IU/mL |
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Inclusion Criteria:
Exclusion Criteria:
Liver transplant patients
Co-Infection with HIV and/or HBV
ALT >10-fold the upper limit of normal i.e. > 400 U/L
Evidence of hepatocellular carcinoma (HCC)
Fibroscan® at screening with a score ≥ 14.5 kPa
Evidence of liver disease due to causes other than chronic HCV infection
Evidence of poorly controlled diabetes (defined as HbA1c > 8%)
History of alcohol or drug abuse within the last 12 months
History or clinical evidence of liver decompensation, e.g. presence of ascites or encephalopathy, or bleeding from esophageal varices
Serum albumin levels < 3.2 g/dL
INR > 1.3 N
Total Bilirubin levels > 2.0 mg/dL unless explained by Gilbert's disease
Platelet Count < 100,000 µL
Absolute Neutrophil counts < 1500 µL (mm3)
Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years
Body Mass Index < 16 or > 35 kg/m2
Females of childbearing potential:
Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom
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| Name | Affiliation | Role |
|---|---|---|
| Gamal Esmat, MD | Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University, Egypt | Principal Investigator |
| Samer El-Kamary, MD | University of Maryland School of Medicine,Baltimore, USA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University | Cairo | Egypt |
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| Pegylated interferon alfa2b | Drug | 1.5 µg/kg once-weekly |
|
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| Ribavirin | Drug | At weight-based dose 800-1400 mg/day (BID, OS) |
|
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Number and percentage of patients with Early Viral Response (EVR), i.e. HCV-RNA decrease ≥ 2 log10 IU/mL 12 weeks after the beginning of the study treatment course |
| 12 weeks after the beginning of the study treatment |
| Undetectable HCV-RNA | Proportion of patients with End Of Treatment (EOT) Response, i.e. undetectable HCV-RNA levels at the end of the study treatment (e.g. at the end of treatment at week 25 or 49) | At the end of study treatment (e.g. at week 25 or 49) |
| Normalization of Serum Alanine Aminotransferase | Proportion of patients with a normalization of Serum Alanine Aminotransferase (ALT <40 U/L) values 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment course; | 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment |
| Number of Participants with adverse events (AEs) | Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73) |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077385 | Silybin |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012838 | Silymarin |
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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