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

NCT03511066 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CT-P27 2.2
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza A

Keywords

efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

CT-P27 90 mg/kg

EXPERIMENTAL

CT-P27 will be administrated once in IV infusion.

Drug: CT-P27 90 mg/kg

CT-P27 45mg/kg

EXPERIMENTAL

CT-P27 will be administrated once in IV infusion.

Drug: CT-P27 45 mg/kg

Placebo

PLACEBO COMPARATOR

Placebo will be administrated once in IV infusion.

Drug: Placebo

Interventions

CT-P27 90 mg/kg DRUG

Influenza A treatment drug.

Also known as: CT-P27

CT-P27 90 mg/kg

CT-P27 45 mg/kg DRUG

Influenza A treatment drug.

Also known as: CT-P27

CT-P27 45mg/kg

Placebo DRUG

Placebo.

Placebo

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Limitations and Caveats

All death, 'treatment-emergent' serious adverse events and 'treatment-emergent' adverse events were summarized.

Results Point of Contact

• Title: Clinical Planning Department Leader
• Organization: Celltrion

contact@celltrion.com

82328505000

Study Officials

• MoonSun Choi

  Celltrion Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: April 27, 2018
• Study Start: December 9, 2016
• Primary Completion: March 9, 2018
• Study Completion: June 15, 2018
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-08

Locations

KR (1)