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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000425-40 | EudraCT Number |
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This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHAA4549A 3600 milligrams (mg) | Experimental | Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration. |
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| MHAA4549A 8400 mg | Experimental | Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration. |
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| Placebo | Placebo Comparator | Participants will receive single-dose placebo by IV administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MHAA4549A | Drug | MHAA4549A will be administered as a single dose by IV administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | Baseline to Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Requiring Hospitalization for Influenza-Related Complications | Baseline to Day 100 | |
| Duration of Hospitalization for Influenza-Related Complications | Baseline to Day 100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama Research Center LLC | Athens | Alabama | 35611 | United States | ||
| WCCT Global, LLC |
Randomization was stratified by onset of influenza-like illness (≤ 36 hours and > 36 hours) and a permuted block randomization method was used to obtain an approximate 1:1:1 ratio of subjects in the 3600 mg MHAA4549A, 8400 mg MHAA4549A, and placebo strata.
The study was conducted at 34 investigational sites in 6 countries including the United States (15 centers), South Africa (12 centers), Canada, Spain, New Zealand (2 centers in each country), and Great Britain (1 center).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received single-dose placebo by intravenous (IV) administration. |
| FG001 | MHAA4549A 3600 mg | Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2016 |
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| Placebo | Drug | Placebo will be administered as a single dose by IV administration. |
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| Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections | Participants with antibiotic usage for secondary bacterial respiratory infections were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory." | Baseline to Day 100 |
| Percentage of Participants With Complications of Influenza | Participants with complications of influenza were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory." | Baseline to Day 100 |
| Percentage of Participants With Influenza A Relapse/Reinfection | Baseline to Day 100 |
| Area Under the Concentration-Time Curve (AUC) of MHAA4549A | The AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was measured in micrograms times hours per milliliter (mcg*h/mL). | Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) |
| Maximum Serum Concentration (Cmax) of MHAA4549A | Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) |
| Time to Alleviation of Symptoms of Influenza A Infection | Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of <=1 and time to a total symptom score of <=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For participants who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration. | Baseline to Day 14 |
| Percentage of Participants With Influenza-Related Deaths | Baseline to Day 100 |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Lalla-Reddy Medical Corporation | Fountain Valley | California | 92708 | United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| Integrity Clinical Research | Doral | Florida | 33166 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| The Community Research Of South Florida | Hialeah | Florida | 33016 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | United States |
| Oceane7 Clinical Research | Miami | Florida | 33144 | United States |
| Central Florida Internists | Saint Cloud | Florida | 34769 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Advanced Research Institute, Inc. | Trinity | Florida | 34655 | United States |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| Professional Research Network of Kansas | Wichita | Kansas | 67205 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Kentucky Lung Clinic | Hazard | Kentucky | 41701 | United States |
| MedPharmics | Metairie | Louisiana | 70006 | United States |
| Acadiana Medicine Clinic | Opelousas | Louisiana | 70570 | United States |
| Anne Arundel Medical Center; Anne Arundel Health System | Annapolis | Maryland | 21401 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| Sinai Grace Hospital | Detroit | Michigan | 48235 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63108 | United States |
| Mercury Street Medical Group | Butte | Montana | 59701 | United States |
| Barrett Clinic, P.C. | La Vista | Nebraska | 68128 | United States |
| Global Medical Institutes, LLC | Princeton | New Jersey | 08540 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Center For Medical Research LLC | Providence | Rhode Island | 02908 | United States |
| Emergency MD | Boiling Springs | South Carolina | 29316 | United States |
| HCCA Clinical Research Solutions | Franklin | Tennessee | 37067 | United States |
| Clinical Research Solutions PC | Knoxville | Tennessee | 37920 | United States |
| Clinical Research Solutions, LLC | Smyrna | Tennessee | 37167 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| Centex Studies | Houston | Texas | 77058 | United States |
| Centex Studies | Pharr | Texas | United States |
| Manna Research Vancouver | Vancouver | British Columbia | V6J 1S3 | Canada |
| Moncton Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Manna Research | Toronto | Ontario | M9W 4L6 | Canada |
| Q and T Research | Gatineau | Quebec | J8Y 6S9 | Canada |
| inVentiv Health Clinique | Québec | G1P 0A2 | Canada |
| Henderson Medical Centre | Auckland | 0612 | New Zealand |
| Optimal Clinical Trials | Auckland | 1010 | New Zealand |
| RMC Medical Research Ltd | Dunedin | New Zealand |
| Tauranga Hospital | Tauranga | 3143 | New Zealand |
| Johese Clinical Research | Centurion | 1692 | South Africa |
| Durban International Clinical Research Site | Durban | 4052 | South Africa |
| Vawda Z Private Practice | Durban | 4091 | South Africa |
| Dr Peter John Sebastian; Dr PJ Sebastian | Durban | 4092 | South Africa |
| Into Research; Life Groenkloof Hospital Medical Centre | Groenkloof | 0181 | South Africa |
| Worthwhile Clinical Trials | Johannesburg | 1500 | South Africa |
| Newtown Clinical Research | Johannesburg | 2113 | South Africa |
| Clinresco Centres (Pty) Ltd | Kempton Park | 1619 | South Africa |
| Peermed Clinical Trial Centre | Kempton Park | 1619 | South Africa |
| Klerksdorp /Tshepong Hospital Complex | Klerksdorp | 2574 | South Africa |
| DJW Navorsing | Krugersdorp | 1739 | South Africa |
| I Engelbrecht Research | Lyttleton | 0157 | South Africa |
| Syzygy Clinical Research; Unit 3 to 7 | Pretoria Gauteng Province | 0087 | South Africa |
| Jongaie Research | Pretoria West | 0183 | South Africa |
| Queenswood CTC | Queenswood | 0121 | South Africa |
| Wits Clinical Research | Soweto | 2013 | South Africa |
| Welkom Clinical Trial Centre | Welkom | 9460 | South Africa |
| Hallym University Sacred Heart Hospital | Anyang-si | 14068 | South Korea |
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | 420-767 | South Korea |
| Gachon University Gil Hospital | Incheon | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Wonju Christian Hospital | Wŏnju | 220-701 | South Korea |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Hospital Mutua de Terrassa; Servicio de Oncologia | Terrassa | Barcelona | 08221 | Spain |
| Hospital San Pedro | Logroño | La Rioja | 26006 | Spain |
| Hospital de Galdakao | Galdacao | Vizcaya | 48960 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Surrey Clinical Research Centre; University of Surrey | Guildford | GU2 7XP | United Kingdom |
| Barts and the London NHS Trust. | London | EC1A 7BE | United Kingdom |
| The James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| FG002 | MHAA4549A 8400 mg | Participants received single-dose MHAA4549A, 8400 mg, by IV administration. |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all participants randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received single-dose placebo by intravenous (IV) administration. |
| BG001 | MHAA4549A 3600 mg | Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration. |
| BG002 | MHAA4549A 8400 mg | Participants received single-dose MHAA4549A, 8400 mg, by IV administration. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Percentage of Participants With Adverse Events (AEs) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. | The safety population included all participants randomized to treatment. | Posted | Number | percentage of participants | Baseline to Day 100 |
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| Secondary | Percentage of Participants Requiring Hospitalization for Influenza-Related Complications | The intent-to-treat infected (ITTI) population included all randomized participants who had an influenza A infection confirmed by central polymerase chain reaction (PCR). | Posted | Number | percentage of participants | Baseline to Day 100 |
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| Secondary | Duration of Hospitalization for Influenza-Related Complications | The intent-to-treat infected (ITTI) population included all randomized participants who had an influenza A infection confirmed by central polymerase chain reaction (PCR). | Posted | Number | days | Baseline to Day 100 |
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| Secondary | Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections | Participants with antibiotic usage for secondary bacterial respiratory infections were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory." | The intent-to-treat infected (ITTI) population included all randomized participants who had an influenza A infection confirmed by central PCR. | Posted | Number | 80% Confidence Interval | percentage of participants | Baseline to Day 100 |
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| Secondary | Percentage of Participants With Complications of Influenza | Participants with complications of influenza were identified by counting participants with AEs containing the terms, "pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory." | ITTI population included all randomized participants who had an influenza A infection confirmed by central PCR. | Posted | Number | 80% Confidence Interval | percentage of participants | Baseline to Day 100 |
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| Secondary | Percentage of Participants With Influenza A Relapse/Reinfection | ITTI population included all randomized participants who had an influenza A infection confirmed by central PCR. | Posted | Number | percentage of participants | Baseline to Day 100 |
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| Secondary | Area Under the Concentration-Time Curve (AUC) of MHAA4549A | The AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was measured in micrograms times hours per milliliter (mcg*h/mL). | Data were collected for this outcome measure. | Posted | Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) |
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| Secondary | Maximum Serum Concentration (Cmax) of MHAA4549A | The pharmacokinetic (PK)-evaluable population included all participants who received MHA4549A. | Posted | Mean | Standard Deviation | mcg/mL | Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours) |
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| Secondary | Time to Alleviation of Symptoms of Influenza A Infection | Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of <=1 and time to a total symptom score of <=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For participants who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration. | ITTI population included all randomized participants who had an influenza A infection confirmed by central PCR. Data are reported for evaluable participants. | Posted | Median | 80% Confidence Interval | hours | Baseline to Day 14 |
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| Secondary | Percentage of Participants With Influenza-Related Deaths | The safety population included all participants randomized to treatment. | Posted | Number | percentage of participants | Baseline to Day 100 |
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Baseline to Day 100
The safety population included all participants randomized to treatment.
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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 | Placebo | Participants received single-dose placebo by intravenous (IV) administration. | 0 | 43 | 0 | 43 | 4 | 43 |
| EG001 | MHAA4549A 3600 mg | Participants received single-dose MHAA4549A, 3600 milligrams (mg), by IV administration. | 0 | 41 | 0 | 41 | 7 | 41 |
| EG002 | MHAA4549A 8400 mg | Participants received single-dose MHAA4549A, 8400 mg, by IV administration. | 0 | 40 | 1 | 40 | 6 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | (+41) 616878333 | global.trial_information@roche.com |
| Oct 31, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000631565 | gedivumab |
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| Male |
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| Not Hispanic or Latino |
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| Not Stated |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Multiple |
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| Unknown |
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