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NCT03511066 Clinical Trial

A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

Influenza A Clinical Trial

Official title:
A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03511066
Other study ID # CT-P27 2.2
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date December 9, 2016
Est. completion date June 15, 2018

Study information
Verified date August 2022
Source Celltrion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

Description:

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.

Recruitment information / eligibility
Status Terminated
Enrollment 228
Est. completion date June 15, 2018
Est. primary completion date March 9, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 64 Years
Eligibility Inclusion Criteria: - Male or Female subjects between the ages of 19 and 64 years, both inclusive - Diagnosed with influenza A at screening using rapid influenza diagnostic test - Onset of influenza symptoms and fever is within 48 hours at screening - At least 2 of symptoms (moderate to severe in intensity) - =38.0'C body temperature at screening Exclusion Criteria: - Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug - Positive influenza B or A+B infection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CT-P27 90 mg/kg
Influenza A treatment drug.
• CT-P27 45 mg/kg
Influenza A treatment drug.
• Placebo
Placebo.

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Resolution of Influenza Symptoms and Fever Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (<37.8) Twice a day (Morning and Evening) from Day 1 to Day 8
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