We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus

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: NCT03961828
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
Eslam Elhawary, Tanta University

Brief Summary:
Patients with transfusion dependent Beta Thalassemia suffer from a high incidence of Hepatitis C infection especially in developed countries as Egypt. In our patients we also found a high correlation between hepatitic C infection and Liver fibrosis. in this study we offer our patients treatment with Direct antiviral drugs and assessed the degree of fibrosis before and after treatment. We tested Hyalornic acid as a predictor of the degree of fibrosis before and after treatment.

Condition or disease Intervention/treatment Phase
Beta-Thalassemia Hepatitis C Drug: Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni] Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Liver Fibrosis by Serum Hyalornic Acid Measurement in β-Thalassemic Children Infected With Hepatitis C Virus Before and After Direct-Acting Antiviral Therapy
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 1, 2019

Arm Intervention/treatment
Experimental: Thalassemia with HCV
The study was carried out upon 50 β-thalassaemic children infected with hepatitis C virus who attended for a medical check-up at the Hematology Unit, Pediatric Department, Tanta University Hospital. Hepatitis C virus infection was diagnosed by serological detection of HCV-Ab, and quantitative detection of serum HCV RNA by polymerase chain reaction (PCR).
Drug: Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni]
The fifty (50) thalassemic children infected with HCV received the new direct-acting antiviral therapy in the form of Ledipasvir (90 mg)/Sofosbuvir (400 mg); (Harvoni) as a single oral tablet /day for 12 weeks Follow up of these patients was performed for 24 weeks. Re-evaluation of these children after 24 weeks from initiation of Ledipasvir/Sofosbuvir treatment was performed by repeating clinical assessment, Fibroscan of liver , laboratory investigations including quantitative HCV RNA by PCR and serum hyaluronic acid measurement.
Other Names:
  • Measuring level of Hyalornic Acid
  • Fibroscan of liver

Primary Outcome Measures :
  1. Treatment of Hepatitis C [ Time Frame: 24 weeks ]
    Becoming PCR negative for Hepatitis C

Secondary Outcome Measures :
  1. Reduction of liver fibrosis [ Time Frame: 6 months ]
    improvement of Fibroscan and Hyalornic Acid Level significantly after treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • β-thalassemic children with superadded hepatitis C virus infection

Exclusion Criteria:

  1. Liver decompansatoin.
  2. Children <12years old.
  3. Patients with viral hepatitis B

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): NCT03961828

Layout table for location information
Pediatric Hematology Unit, Faculty of Medicine, Tanta University
Tanta, Gharbia Governorate, Egypt, 31527
Sponsors and Collaborators
Tanta University
Layout table for additonal information
Responsible Party: Eslam Elhawary, Lecturer of pediatric hemato-oncology and bone marrow transplantation, Tanta University
ClinicalTrials.gov Identifier: NCT03961828    
Other Study ID Numbers: 31747/08/17
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents