Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2019-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03743727

Hepatitis C Genotype 4

UNKNOWN PHASE4

Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

NCT05091008

Hepatitis C, Chronic

COMPLETED PHASE2

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

NCT03080415

Hepatitis C Genotype 4

COMPLETED PHASE3

Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

NCT03343444

Hepatitis C Virus Infection, Response to Therapy of

UNKNOWN PHASE3

Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children

NCT05854511

HCV

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general population. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.

Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for liver transplant; approximately 170 million people worldwide are chronically infected. There is general consensus that HCV elimination is associated with strong and sustained CD4+ and CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins, however, they are not maintained in patients who develop chronic disease . A variety of factors purportedly contribute to the dimi-nished T cell responses observed in chronically infected patients, including an im-paired dendritic cell (DC) function.

The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a con-dition requiring complex therapies with unsatisfactory outcomes to one that can be easily treated with few contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment of adults with chronic hepatitis C. Investigation into DAAs for children has been slower.

For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus ribavirin for genotype 2 or 3 infection have been described in full-length articles.

A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection. Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir, pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with genotype 4 infection.

Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity to elicit primary T cell responses. Two major subsets of DC can be identified from human peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C, Chronic Children, Only

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sofosbovir/Ledipasvir Daily

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

Group Type EXPERIMENTAL

Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)

Intervention Type DRUG

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children with chronic HCV
* age 3- 12 y old
* weight 17- 35kg
* Basal HCV viremia less than 6.8 log IU/mL
* Treatment-naive
* No cirrhosis

Exclusion Criteria

* Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV
* age below 3 years or above 12 years
* body weight less than 17 or more than 35 Kg
* HCV/HIV coinfection.
* Patients with HCV infection and HCC.
* Patients with HCV infection and underlying cardiac comorbidities
* Decompensated patients with HCV
* Hypoalbuminemia of \< 3.5g/dL.
* International normalised ratio (INR) \>2.
* Advanced fibrosis scoring by transient elastography (F 4 broScan)
* Any concomitant malignancy.
* Parents' refusal for participation of their children in the study.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mostafa M. Sira

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR