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

NCT ID: NCT05091008

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-03-10

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

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HCV without co-morbidities

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

Group Type: ACTIVE_COMPARATOR

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

Intervention Type: DRUG

proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received 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. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)

HCV with co-morbidities

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

Group Type: ACTIVE_COMPARATOR

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

Intervention Type: DRUG

proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received 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. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)

Interventions

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received 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. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)

Intervention Type: DRUG

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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Children Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Noaman

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Noaman, MD

Role: STUDY_DIRECTOR

Lecturer

Locations

Mansoura University Children Hospital

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

MansouaUCH0322

Identifier Type: -

Identifier Source: org_study_id