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This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety & efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Therapy LDV and SOF | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined therapy LDV and SOF | Drug | All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | The presence of any adverse effects will be used to characterize this outcome measure. | During the 12 weeks of treatment. |
| Sustained Viral Clearance | HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml. | At Week 12 after end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mamdouh A. Ahmed | Contact | 02-01221707770 | dr.yassinabdelghaffar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tawhida Y. Abdel Ghaffar, MD | Yassin Abdel Ghaffar Charity Center for Liver Disease and Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research | Recruiting | Madīnat an Naşr | Cairo Governorate | Egypt |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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