Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

Study Overview
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Brief Summary
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Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Official Title
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Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

Conditions
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Hepatitis C Virus Infection, Response to Therapy of

Intervention / Treatment
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* Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)
* Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent. 12-18 years HCV RNA ≥ 104 IU/mL at screening. Confirmed chronic HCV infection as documented by either: a. a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or Screening ECG without clinically significant abnormalities. Patients must have the following laboratory parameters at screening: ALT (Alanine transaminase) ≤ 10 x the upper limit of normal (ULN) AST (Aspartate Aminotransferase) ≤ 10 x ULN Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female patients Platelets > 50,000 cells/mm3 INR (international normalized ratio) ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR Albumin ≥ 3 g/dL HbA1c ≤ 10% Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation Patient has not been treated with any investigational drug or device within 30 days of the screening visit. Exclusion Criteria: Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis). Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV). History of solid organ transplantation. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome). History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug. History of significant pulmonary disease, significant cardiac disease or porphyria. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Treatment-naïve is defined as having never received treatment for HCV with any interferon (IFN), ribavirin , or other approved or experimental HCV specific direct acting antivirals. | Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)<br>* Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks<br>* Other names: Normal track;|
| Active Comparator: Arm 2<br>Treatment-experienced is defined as: IFN Intolerant Non-response Relapse/Breakthrough | Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)<br>* Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks<br>* Other names: Normal track;|
| Experimental: Short Track<br>Treatment-naïve or Treatment-experienced who achived very rapid virological responce - Negative HCV PCR after treatment with (Sofosbuvir 400mg/Ledipasvir 90mg) for 1 week | Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)<br>* Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks<br>* Other names: Short track;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR12 | sustained viral response 12 weeks after discontinuation of therapy (SVR12) | 12 weeks after discontinuation of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR4 | sustained viral response 4 weeks after discontinuation of therapy (SVR4) | 4 weeks after discontinuation of therapy |