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

NCT03961828 | Completed Phase 4

• 1 other identifier: 31747/08/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Beta-Thalassemia; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Treatment of Hepatitis C

  Becoming PCR negative for Hepatitis C

  24 weeks

Secondary Outcomes (1)

• Reduction of liver fibrosis

  6 months

Study Arms (1)

Thalassemia with HCV

EXPERIMENTAL

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]

Interventions

Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni] DRUG

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.

Also known as: Measuring level of Hyalornic Acid, Fibroscan of liver

Thalassemia with HCV

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• β-thalassemic children with superadded hepatitis C virus infection

You may not qualify if:

• Liver decompansatoin.
• Children \<12years old.
• Patients with viral hepatitis B

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Pediatric Hematology Unit, Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

beta-Thalassemia; Hepatitis C

Interventions

ledipasvir; Sofosbuvir; ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatric hemato-oncology and bone marrow transplantation

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: October 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)