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

Primary Purpose

Influenza A

Status

Terminated

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

CT-P27 90 mg/kg

CT-P27 45 mg/kg

Placebo

About this trial

This is an interventional treatment trial for Influenza A focused on measuring efficacy, safety

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

CT-P27 90 mg/kg

CT-P27 45mg/kg

Placebo

Arm Description

CT-P27 will be administrated once in IV infusion.

Placebo will be administrated once in IV infusion.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT03511066

First Posted

February 28, 2018

Last Updated

October 28, 2022

Sponsor

Celltrion

1. Study Identification

Unique Protocol Identification Number

NCT03511066

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

CT-P27 2.2 is inactivated

Study Start Date

December 9, 2016 (Actual)

Primary Completion Date

March 9, 2018 (Actual)

Study Completion Date

June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celltrion

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza A

Keywords

efficacy, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CT-P27 90 mg/kg

Arm Type

Experimental

Arm Description

CT-P27 will be administrated once in IV infusion.

Arm Title

CT-P27 45mg/kg

Arm Type

Experimental

Arm Description

CT-P27 will be administrated once in IV infusion.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo will be administrated once in IV infusion.

Intervention Type

Drug

Intervention Name(s)

CT-P27 90 mg/kg

Other Intervention Name(s)

CT-P27

Intervention Description

Influenza A treatment drug.

Intervention Type

Drug

Intervention Name(s)

CT-P27 45 mg/kg

Other Intervention Name(s)

CT-P27

Intervention Description

Influenza A treatment drug.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo.

Primary Outcome Measure Information:

Title

Time to Resolution of Influenza Symptoms and Fever

Description

Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (<37.8)

Time Frame

Twice a day (Morning and Evening) from Day 1 to Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MoonSun Choi

Organizational Affiliation

Celltrion Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Korea University Guro Hospital

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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