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

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)

Study Overview

• Status: Unknown
• Conditions: Hepatitis C Virus Infection, Response to Therapy of
• Intervention / Treatment: Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg); Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 36681
      • Egyptian Liver Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. 12-18 years
3. HCV RNA ≥ 104 IU/mL at screening.

4. 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

5. Screening ECG without clinically significant abnormalities.

6. 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
7. Patient has not been treated with any investigational drug or device within 30 days of the screening visit.

Exclusion Criteria:

1. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis).
2. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
3. History of solid organ transplantation.
4. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome).
5. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
6. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug.
7. History of significant pulmonary disease, significant cardiac disease or porphyria.
8. History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
9. Donation or loss of more than 400 mL blood within 2 months prior to Baseline/Day 1.
10. Known hypersensitivity to the study investigational medicinal product, the metabolites, or formulation excipients.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; 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); Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks; Other Names: Normal track
Active Comparator: Arm 2; Treatment-experienced is defined as: IFN Intolerant; Non-response; Relapse/Breakthrough	Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg); Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks; Other Names: Normal track
Experimental: Short Track; 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); Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks; Other Names: Short track

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Egyptian Liver Hospital
• Investigators: Principal Investigator: Gamal Shiha, MD, Egyptian Liver Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Ledipasvir
• Other Study ID Numbers: PED-ELH-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No