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

Sponsor

Egyptian Liver Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03343444

Collaborator

(none)

Enrollment

Location

Arms

25.5

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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 adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus Infection, Response to Therapy of	Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) Drug: 8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2017

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

May 31, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

SVR12 [12 weeks after discontinuation of therapy]
sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Secondary Outcome Measures

SVR4 [4 weeks after discontinuation of therapy]
sustained viral response 4 weeks after discontinuation of therapy (SVR4)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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.