- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05091008
Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children
The Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Naïve Children
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Mansoura University Children Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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)
|
Active Comparator: 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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: at 4 weeks after discontinuation of therapy
|
Proportion of patients with negative PCR
|
at 4 weeks after discontinuation of therapy
|
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.
Time Frame: At 12 weeks after discontinuation of therapy
|
Proportion of patients still with negative PCR
|
At 12 weeks after discontinuation of therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: At 4 weeks after discontinuation of therapy
|
Assessment of possible adverse effects
|
At 4 weeks after discontinuation of therapy
|
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.
Time Frame: At 12 weeks after discontinuation of therapy
|
Assessment of possible new adverse effects not detected at 4 weeks after discontinuation of therapy
|
At 12 weeks after discontinuation of therapy
|
Collaborators and Investigators
Investigators
- Study Director: Ahmed M Noaman, MD, Lecturer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Sofosbuvir
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
Other Study ID Numbers
- MansouaUCH0322
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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