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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080415
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Egyptian Cure Bank
Society of Friends of Liver Patients in the Arab World (SLPAW)
Information provided by (Responsible Party):
Dr. Tawhida Yassin Abdel Ghaffar, Yassin Abdelghaffar Charity Center for Liver Disease and Research

Tracking Information
First Submitted Date  ICMJE February 22, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date June 6, 2018
Actual Study Start Date  ICMJE March 18, 2017
Actual Primary Completion Date February 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
  • 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.
  • Sustained Viral Clearance [ Time Frame: At Week 12 after end of treatment. ]
    HCV RNA testing will be used to determine if the target of viral clearance has been established.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
Official Title  ICMJE The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Genotype 4
Intervention  ICMJE Drug: Combined Therapy SOF and DCV

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
Study Arms  ICMJE Experimental: Combined Therapy SOF and DCV
Intervention: Drug: Combined Therapy SOF and DCV
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2018
Actual Primary Completion Date February 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 8-18 years
  2. Sex: both sexes
  3. Naïve patients, with chronic HCV infection

Exclusion Criteria:

  1. Co-infection with Hepatitis B virus (HBV)
  2. Other associated chronic liver illness
  3. Cirrhotic patients (as indicated by biopsy, fibroscan(F4)
  4. Patients with history of hematemesis (non cirrhotic portal hypertension)
  5. Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03080415
Other Study ID Numbers  ICMJE DCV SOF T 2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Tawhida Yassin Abdel Ghaffar, Yassin Abdelghaffar Charity Center for Liver Disease and Research
Study Sponsor  ICMJE Yassin Abdelghaffar Charity Center for Liver Disease and Research
Collaborators  ICMJE
  • Egyptian Cure Bank
  • Society of Friends of Liver Patients in the Arab World (SLPAW)
Investigators  ICMJE
Principal Investigator: Tawhida Y. Abdel Ghaffar, M.D. Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
PRS Account Yassin Abdelghaffar Charity Center for Liver Disease and Research
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP