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

NCT05091008 | Completed Phase 2 DMC

• 1 other identifier: MansouaUCH0322
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis C; Egyptian children; Sofosbuvir; Ledipasvir

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Proportion of patients still with negative PCR

  At 12 weeks after discontinuation of therapy

Secondary Outcomes (2)

• 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 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.

  At 12 weeks after discontinuation of therapy

Study Arms (2)

HCV without co-morbidities

ACTIVE COMPARATOR

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

Drug: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

HCV with co-morbidities

ACTIVE COMPARATOR

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

Drug: Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

Interventions

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet 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; HCV without co-morbidities

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed M Noaman, MD

  Lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 25, 2021
• Study Start: March 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: March 10, 2020
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

EG (1)