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

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ClinicalTrials.gov Identifier: NCT03743727
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Tawhida Yassin Abdel Ghaffar, Yassin Abdelghaffar Charity Center for Liver Disease and Research

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Genotype 4 Drug: Combined therapy LDV and SOF Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Combined Therapy LDV and SOF Drug: Combined therapy LDV and SOF
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).
Other Name: ledipasvir and sofosbuvir




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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, ..)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743727


Contacts
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Contact: Mamdouh A. Ahmed 02-01221707770 dr.yassinabdelghaffar@gmail.com

Locations
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Egypt
Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research Recruiting
Nasr City, Cairo, Egypt
Contact: Mamdouh A. Ahmed    02-01221707770    dr.yassinabdelghaffar@gmail.com   
Sponsors and Collaborators
Yassin Abdelghaffar Charity Center for Liver Disease and Research
Investigators
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Principal Investigator: Tawhida Y. Abdel Ghaffar, MD Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

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Responsible Party: Dr. Tawhida Yassin Abdel Ghaffar, Professor, Yassin Abdelghaffar Charity Center for Liver Disease and Research
ClinicalTrials.gov Identifier: NCT03743727     History of Changes
Other Study ID Numbers: LDV SOF T 2018
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents