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

NCT03343444 | Unknown Phase 3 DMC

• 1 other identifier: PED-ELH-2017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Hepatitis C Virus Infection, Response to Therapy of

Outcome Measures

Primary Outcomes (1)

• SVR12

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

  12 weeks after discontinuation of therapy

Secondary Outcomes (1)

• SVR4

  4 weeks after discontinuation of therapy

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

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)

Arm 2

ACTIVE COMPARATOR

Treatment-experienced is defined as: 1. IFN Intolerant 2. Non-response 3. Relapse/Breakthrough

Drug: 12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

Short Track

EXPERIMENTAL

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)

Interventions

12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) DRUG

Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks

Also known as: Normal track

Arm 1; Arm 2

8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg) DRUG

Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks

Also known as: Short track

Short Track

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willing and able to provide written informed consent.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egyptian Liver Hospital: lead

Study Sites (1)

Egyptian Liver Hospital

Al Mansurah, Dakahlia Governorate, 36681, Egypt

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; ledipasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Gamal Shiha, MD

  Egyptian Liver Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: November 17, 2017
• Study Start: April 15, 2017
• Primary Completion: November 1, 2018
• Study Completion: May 31, 2019
• Last Updated: May 24, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)