Clinical trial NCT05091008: Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children
Official title: The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naïve Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Chronic hepatitis C
Egyptian children
Sofosbuvir
Ledipasvir
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: * 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).

Primary outcomes:
measure: 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.
timeFrame: at 4 weeks after discontinuation of therapy
measure: 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.
timeFrame: At 12 weeks after discontinuation of therapy
Secondary outcomes:
measure: 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.
timeFrame: At 4 weeks after discontinuation of therapy
measure: 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.
timeFrame: At 12 weeks after discontinuation of therapy
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children Hospital
Study officials:
affiliation: Lecturer
name: Ahmed M Noaman, MD
role: STUDY_DIRECTOR
References: