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Completed

NCT Number: NCT03080415

Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir

This is an open, uncontrolled pilot study of thirty 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 sofosbuvir (SOF) and daclatasvir (DCV) 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.

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Key information

Conditions

Hepatitis C Genotype 4

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Madīnat an Naşr, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 8-18 years
  • Sex: both sexes
  • Naïve patients, with chronic HCV infection

Exclusion criteria

  • Co-infection with Hepatitis B virus (HBV)
  • Other associated chronic liver illness
  • Cirrhotic patients (as indicated by biopsy, fibroscan(F4)
  • Patients with history of hematemesis (non cirrhotic portal hypertension)
  • Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)

Treatment and study plan

Combined Therapy SOF and DCV

Drug

1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day

SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients

DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients

Other names: sofosbuvir, daclatasvir

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events

    Time frame: During the 12 weeks of treatment.

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

  2. Sustained Viral Clearance

    Time frame: At Week 12 after end of treatment.

    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.

Sponsors and collaborators

Lead sponsor

Yassin Abdelghaffar Charity Center for Liver Disease and Research

Other

Collaborators

  • Egyptian Cure Bank
  • Society of Friends of Liver Patients in the Arab World (SLPAW)

Registry information

Official study title

The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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