Hyalornic Acid Level in β-Thalassemic Children Treated for Hepatitis C Virus
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ClinicalTrials.gov Identifier: NCT03961828 |
Recruitment Status :
Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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Condition or disease | Intervention/treatment | Phase |
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Beta-Thalassemia Hepatitis C | Drug: Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni] | Phase 4 |

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 |
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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).
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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:
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- Treatment of Hepatitis C [ Time Frame: 24 weeks ]Becoming PCR negative for Hepatitis C
- Reduction of liver fibrosis [ Time Frame: 6 months ]improvement of Fibroscan and Hyalornic Acid Level significantly after treatment

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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:
- Liver decompansatoin.
- Children <12years old.
- Patients with viral hepatitis B

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
Egypt | |
Pediatric Hematology Unit, Faculty of Medicine, Tanta University | |
Tanta, Gharbia Governorate, Egypt, 31527 |
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 |
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 |
Hepatitis A Hepatitis C Hepatitis Thalassemia beta-Thalassemia Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Flaviviridae Infections Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Sofosbuvir Ledipasvir, sofosbuvir drug combination Ledipasvir Antiviral Agents Anti-Infective Agents |