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Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years With Influenza

NCT06669351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-08-13

No results posted yet for this study

Summary

A multicenter, randomized, double-blind, positive controlled, phase III trial to evaluate the safety and efficacy of ZX-7101A tablets versus oseltamivir phosphate suspension in children aged ≥5 years and \< 12 years with uncomplicated influenza.

Conditions

  • Respiratory Viral Infection

Interventions

DRUG

ZX-7101A

On day1: Take two tablets of ZX-7101A orally once (specification: 10mg/ tablet) with appropriate amount of warm water

OTHER

Placebo for ZX-7101A tablet

Placebo for ZX-7101A tablet: The appearance and properties of placebo tablets were identical to those of the trial drug ZX-7101A tablets. On Day 1, two placebo for ZX-7101A tablets were taken orally with appropriate warm water.

DRUG

Oseltamivir phosphate dry suspension

Drug: Oseltamivir phosphate dry suspension: From Day1 to Day 5 : Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

OTHER

Placebo for Oseltamivir phosphate dry suspension:

Drug: Placebo for Oseltamivir phosphate dry suspension: From Day1 to Day 5 : Placebo for Oseltamivir phosphate suspension was orally administered twice a day, dose according to the label.

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Hanmin Liu, MD · Children's Hospital, Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2025-07-15
Completion
2025-07-15

Countries

  • China

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 NCT06669351 on ClinicalTrials.gov