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Pharmacokinetics, Safety, Efficacy and Acceptability of Daclatasvir Plus Sofosbuvir in HCV-infected Children

NCT05854511 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-11

No results posted yet for this study

Summary

This is an interventional, single center, single arm clinical trial to assess the pharmacokinetics, safety, efficacy, and acceptability of daclatasvir plus sofosbuvir in treatment-naïve children weighing between 14 and 35 kg with chronic HCV GT 1-6 infection.

Conditions

  • HCV

Interventions

DRUG

Sofosbuvir 200 MG Oral Tablet plus Daclatasvir 30 mg Oral tablets

Daclatasvir 30 mg orally once daily plus Sofosbuvir at a dose of 200 mg (2x 100 mg tablets) orally once daily for 12 weeks.

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Manal H. El-Sayed, MD · Department of Paediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-05
Primary Completion
2023-12-31
Completion
2024-04-13

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05854511 on ClinicalTrials.gov