Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

NCT03743727 | Unknown Phase 4

• 1 other identifier: LDV SOF T 2018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety \& efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.

Conditions

Hepatitis C Genotype 4

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events

  The presence of any adverse effects will be used to characterize this outcome measure.

  During the 12 weeks of treatment.

• Sustained Viral Clearance

  HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.

  At Week 12 after end of treatment.

Study Arms (1)

Combined Therapy LDV and SOF

EXPERIMENTAL

Drug: Combined therapy LDV and SOF

Interventions

Combined therapy LDV and SOF DRUG

All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).

Also known as: ledipasvir and sofosbuvir

Combined Therapy LDV and SOF

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HCV chronic infection
• Treatment naive and treatment experienced (previous interferon treatment)
• No cirrhosis or compensated cirrhosis

You may not qualify if:

• Co-infection with Hepatitis B (HBV)
• Other associated chronic liver illness
• Patients with history of hematemesis (non-cirrhotic portal hypertension)
• Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
• Patients on drugs known to interact unfavorably (Amioidarone, ..)

Sponsors & Collaborators

• Yassin Abdelghaffar Charity Center for Liver Disease and Research: lead

Study Sites (1)

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Madīnat an Naşr, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination

Study Officials

• Tawhida Y. Abdel Ghaffar, MD

  Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mamdouh A. Ahmed

CONTACT

02-01221707770; dr.yassinabdelghaffar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: August 1, 2018
• Primary Completion: March 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)