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| ID | Type | Description | Link |
|---|---|---|---|
| 2021 003162 12 | EudraCT Number |
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This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Garadacimab | Experimental | Administered IV and SC |
|
| Placebo | Placebo Comparator | Administered IV and SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garadacimab | Drug | Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs) | A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event. | Up to 22 weeks |
| Percentage of Participants With TE SAEs | A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event | Up to 22 weeks |
| Number of Participants With TE Adverse Events of Special Interests (AESIs) | The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis [e.g., localized thrombosis associated with vascular access] was not considered an AESI), and Severe hypersensitivity including anaphylaxis. | Up to 22 weeks |
| Percentage of Participants With TE-AESIs | The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis [e.g., localized thrombosis associated with vascular access] was not considered an AESI), and Severe hypersensitivity including anaphylaxis. | Up to 22 weeks |
| Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab | At Day 36 and Day 64 | |
| Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab | After dosing on Day 64 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| Pulmonary Associates Clinical Trials AZ |
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
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A total of 131 potential participants were screened for eligibility. Out of these, 81 participants met all selection criteria and were enrolled in the study, and 50 individuals failed to meet the selection criteria and were not enrolled in the study.
This study was conducted at 47 study sites in 11 countries (Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Poland, Spain, the United Kingdom [UK], and the United States of America [USA]). No participants from Italy were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Garadacimab | Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses. |
| FG001 | Placebo | Participants received a matching placebo IV loading dose, followed by 3 SC doses. |
| 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 | Yes | No | No | Study Protocol | Oct 18, 2022 | Oct 10, 2024 |
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| Placebo | Drug | Participants received a matching placebo IV loading dose, followed by 3 SC doses. |
|
| At Day 36 and Day 92 after the first treatment |
| Percentage of Participants With Garadacimab Induced ADAs in Plasma | At Day 36 and Day 92 after the first treatment |
| Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs) | Up to 14 weeks after treatment |
| Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs | Up to 14 weeks after treatment |
| Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab | After dosing on Day 64 |
| Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab | After dosing on Day 64 |
| Ctrough After IV Administration of Garadacimab | At Day 8 |
| Cmax After IV Administration of Garadacimab | After dosing on Day 1 |
| Tmax After IV Administration of Garadacimab | After dosing on Day 1 |
| Mean Change From Baseline in FXIIa-mediated Kallikrein Activity | Baseline and at Day 92 |
| Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity | Percent baseline is calculated by using the formula visit value / baseline value multiplied by 100, percent baseline is reported as percentage in the outcome measure. | Baseline and at Day 92 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| National Institute of Clinical Research | Huntington Beach | California | 92647 | United States |
| University of Southern California - Center for Advanced Lung Disease | Los Angeles | California | 90033 | United States |
| University of California Irvine | Orange | California | 92868 | United States |
| Meris Clinical Research | Brandon | Florida | 33511 | United States |
| Reliant Medical Research | Miami | Florida | 33165 | United States |
| US Associates in Research LLC | Miami | Florida | 33175 | United States |
| Lakes Research | Miami Lakes | Florida | 33014 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Jadestone Clinical Research | Silver Spring | Maryland | 20904 | United States |
| Hannibal Clinic | Hannibal | Missouri | 63401 | United States |
| Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Superior Clinical Research | Smithfield | North Carolina | 27577 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Temple University TMS | Philadelphia | Pennsylvania | 19140 | United States |
| Clinical Trial Center of Middle Tennesse | Franklin | Tennessee | 37067 | United States |
| Elite Medical Research | Dallas | Texas | 75230 | United States |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | United States |
| Baylor Scott and White Health - Advanced Lung Disease Specialists | Dallas | Texas | 75246 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Medizinische Univerität Graz | Graz | 8036 | Austria |
| Kepler Universitätsklinikum | Linz | 4021 | Austria |
| Universitair Ziekenhuis (UZ) Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire Sart Tilman | Liège | 4000 | Belgium |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Dr. Syed Anees Medicine Professional Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| Odense Universitetshospital - Lungemedicinsk Forskningsenhed | Odense | 5000 | Denmark |
| Fachkrankenhaus Coswig GmbH | Coswig | 01640 | Germany |
| Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum) | Essen | 45239 | Germany |
| Medizinische Hochschule Hannover - Klinik für Pneumologie | Hanover | 30625 | Germany |
| Petrus Krankenhaus Wuppertal | Wuppertal | 42283 | Germany |
| Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia | Foggia | 71122 | Italy |
| Centrum Medycyny Oddechowej Bialymstoku | Bialystok | 15-044 | Poland |
| Twoja Przychodnia Centrum Medyczne Nowa Sol | Nowa Sól | 67-100 | Poland |
| Centrum Badań Klinicznych NZOZ | Wroclaw | 51-162 | Poland |
| Giromed Institute, SLP | Barcelona | 08006 | Spain |
| Hospital Universitario Puerta del Mar (HUPM) | Cadiz | 11009 | Spain |
| The Churchill Hospital - Oxford University Hospitals NHS Trust | Oxford | MD | OX3 7LE | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| Altnagelvin Area Hospital | Londonderry | BT47 6SB | United Kingdom |
| Manchester Univ NHS - Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Garadacimab | Participants received garadacimab IV loading dose followed by 3 SC doses. |
| BG001 | Placebo | Participants received a matching placebo IV loading dose, followed by 3 SC doses. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs) | A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event. | This analysis was performed on the safety analysis set (SAS). The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. | Posted | Count of Participants | Participants | No | Up to 22 weeks |
|
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| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants With TE SAEs | A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. | Posted | Number | Percentage of participants | Up to 22 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With TE Adverse Events of Special Interests (AESIs) | The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis [e.g., localized thrombosis associated with vascular access] was not considered an AESI), and Severe hypersensitivity including anaphylaxis. | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. | Posted | Count of Participants | Participants | No | Up to 22 weeks |
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| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With TE-AESIs | The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis [e.g., localized thrombosis associated with vascular access] was not considered an AESI), and Severe hypersensitivity including anaphylaxis. | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. | Posted | Number | Percentage of participants | Up to 22 weeks |
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified timepoint. | Posted | Count of Participants | Participants | No | At Day 36 and Day 92 after the first treatment |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Garadacimab Induced ADAs in Plasma | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified timepoint. | Posted | Number | Percentage of participants | At Day 36 and Day 92 after the first treatment |
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| |||||||||||||||||||||||||||||||
| Primary | Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs) | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. | Posted | Count of Participants | Participants | No | Up to 14 weeks after treatment |
|
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs | This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. | Posted | Number | Percentage of participants | Up to 14 weeks after treatment |
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| Secondary | Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab | This analysis was performed on pharmacokinetic analysis set (PKS). The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified timepoint. | Posted | Mean | Standard Deviation | Microgram/milliliter (ug/mL) | At Day 36 and Day 64 |
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| Secondary | Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab | This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ug/mL | After dosing on Day 64 |
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| ||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab | This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Median | Full Range | Hours (h) | After dosing on Day 64 |
|
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| Secondary | Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab | This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | h*ug/mL | After dosing on Day 64 |
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| Secondary | Ctrough After IV Administration of Garadacimab | This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ug/mL | At Day 8 |
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| Secondary | Cmax After IV Administration of Garadacimab | This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | ug/mL | After dosing on Day 1 |
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| Secondary | Tmax After IV Administration of Garadacimab | This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received >= 1 dose of garadacimab with >= 1 measurable concentration of garadacimab after administration. | Posted | Median | Full Range | h | After dosing on Day 1 |
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| Secondary | Mean Change From Baseline in FXIIa-mediated Kallikrein Activity | This analysis was performed on pharmacodynamic analysis set (PDS). The PDS was defined as all participants in the SAS for whom analysis results were obtained for >= 1 of the exploratory biomarkers of interest. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Nanomoles/liter/minutes (nmol/L/mins) | Baseline and at Day 92 |
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| Secondary | Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity | Percent baseline is calculated by using the formula visit value / baseline value multiplied by 100, percent baseline is reported as percentage in the outcome measure. | This analysis was performed on PDS. The PDS was defined as all participants in the SAS for whom analysis results were obtained for >= 1 of the exploratory biomarkers of interest. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Percent baseline | Baseline and at Day 92 |
|
|
Up to 22 weeks
This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
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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 | Garadacimab | Participants received garadacimab IV loading dose followed by 3 SC doses. | 1 | 40 | 5 | 40 | 18 | 40 |
| EG001 | Placebo | Participants received a matching placebo IV loading dose, followed by 3 SC doses. | 1 | 41 | 2 | 41 | 19 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA v26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | CSL Behring LLC | 610 878 4000 | +1 | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2022 | Oct 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Austria |
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| Belgium |
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| United States |
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| Poland |
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| Denmark |
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| United Kingdom |
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| Australia |
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| Germany |
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| Spain |
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