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

Phase 2

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

• Registration Number: NCT05091008
• Lead Sponsor: Mansoura University Children Hospital

Brief Summary

Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influence their quality of life. Many efforts have been directed toward the investment of effective drugs with high safety profiles and with oral administration for better compliance. The development of a new direct-acting antiviral (DAA) made it possible to achieve these goals.

Detailed Description

The calculated sample size of the study was ....participants at 5% level of significance and 80 % power, using the following formula:

N= (Z1-α/2+Z1-β) 2 σ1\* σ2 / δ 2 This study aims to evaluate the safety and efficacy of the combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infections.

Patients will receive Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at a fixed time with or without food for 12 weeks. Visits will be arranged at 4, 8, and 12 weeks. Patients will have easy access to the pediatric hepatology unit and the treating physician if any urgent problem happens in between the visits.

The SPSS software version 24, SPSS was used for data processing

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-08-30
• Study Completion: 2020-03-10
• Study First Submitted: 2021-09-24
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-10-25
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Chronic HCV infection (≥ 6 months).
  • Weighing at least 35 kg.
  • Treatment-naïve children with chronic HCV infection without cirrhosis or with compensated cirrhosis.
  • Parent or legal guardian must provide written informed consent.

Exclusion Criteria

• Patients with comorbidity of chronic medical illness (decompensated heart disease, severe renal impairment (GFR < 30) or ESRD, uncontrolled DM).
  • Concomitant HBV or HIV infection.
  • Medications (Amiodarone, beta-blockers).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCV with co-morbidities	Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet	Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks
HCV without co-morbidities	Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet	Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naïve, chronic HCV infection, genotype 4.	At 12 weeks after discontinuation of therapy	Proportion of patients still with negative PCR

Secondary Outcome Measures

Name	Time	Method
Evaluate the safety of Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), in children with treatment-Naïve, chronic HCV infection, genotype 4.	At 12 weeks after discontinuation of therapy	Assessment of possible new adverse effects not detected at 4 weeks after discontinuation of therapy

Trial Locations

Locations (1)

Mansoura University Children Hospital; 🇪🇬 Mansoura, Egypt