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CT-P27 2.2 is inactivated
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P27 90 mg/kg | Experimental | CT-P27 will be administrated once in IV infusion. |
|
| CT-P27 45mg/kg | Experimental | CT-P27 will be administrated once in IV infusion. |
|
| Placebo | Placebo Comparator | Placebo will be administrated once in IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P27 90 mg/kg | Drug | Influenza A treatment drug. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MoonSun Choi | Celltrion Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P27 90 mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 90 mg/kg: Influenza A treatment drug. |
| FG001 | CT-P27 45mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 45 mg/kg: Influenza A treatment drug. |
| FG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P27 90 mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 90 mg/kg: Influenza A treatment drug. |
| BG001 | CT-P27 45mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 45 mg/kg: Influenza A treatment drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | The intent-to-treat-infected (ITTI) population defined as all randomized subjects with confirmed influenza A by quantitative polymerase chain reaction (qPCR) or cell culture. | Posted | Median | 95% Confidence Interval | Days | Twice a day (Morning and Evening) from Day 1 to Day 8 |
|
up to Day 110/end-of-study (EOS) visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P27 90 mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 90 mg/kg: Influenza A treatment drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
All death, 'treatment-emergent' serious adverse events and 'treatment-emergent' adverse events were summarized.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Planning Department Leader | Celltrion | 82328505000 | contact@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2018 | Feb 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2018 | Feb 27, 2020 | SAP_001.pdf |
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| CT-P27 45 mg/kg | Drug | Influenza A treatment drug. |
|
|
| Placebo | Drug | Placebo. |
|
| BG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Positive rapid influenza diagnostic test at screening | Count of Participants | Participants |
|
| Influenza A confirmation | Count of Participants | Participants |
|
| Influenza A subtype | Count of Participants | Participants |
|
| Total influenza symptom score at screening | Average score of symptoms (Cough, Sore throat, Headache, Nasal congestion, Feeling feverish, Body aches and pains, Fatigue [Tiredness], Neck pain, Interrupted sleep and Loss of appetite) by Influenza Intensity and Impact Questionnaire (FluiiQ™): 0=None, 1=Mild, 2=Moderate, 3=Severe | Mean | Full Range | Averaged for each symptoms' score |
|
| Body temperature at screening | Mean | Standard Deviation | °C |
|
CT-P27 will be administrated once in IV infusion.
CT-P27 45 mg/kg: Influenza A treatment drug.
| OG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. |
|
|
| 0 |
| 88 |
| 1 |
| 88 |
| 8 |
| 88 |
| EG001 | CT-P27 45mg/kg | CT-P27 will be administrated once in IV infusion. CT-P27 45 mg/kg: Influenza A treatment drug. | 0 | 90 | 5 | 90 | 8 | 90 |
| EG002 | Placebo | Placebo will be administrated once in IV infusion. Placebos: Placebo. | 0 | 50 | 1 | 50 | 6 | 50 |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
|
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