Status:
UNKNOWN
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
Lead Sponsor:
Egyptian Liver Hospital
Conditions:
Hepatitis C Virus Infection, Response to Therapy of
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
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 adoles...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03343444
Start Date
April 15 2017
End Date
May 31 2019
Last Update
May 24 2018
Active Locations (1)
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1
Egyptian Liver Hospital
Al Mansurah, Dakahlia Governorate, Egypt, 36681