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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508744-22-00 | EU Trial (CTIS) Number |
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Sponsor decision, not for safety reasons.
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This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 [COVID-19] POTS [post-COVID-POTS]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro20 | Biological | IgPro20 is a 20% ready-to-use liquid formulation of polyvalent human immunoglobulin G (IgG) for subcutaneous (SC) administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension]) | The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of >=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure [SBP; orthostatic hypotension]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS. | At Baseline and at Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31) | The COMPASS-31 was a self-reported questionnaire that measures autonomic symptoms across six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. The OI domain assesses symptoms including faintness, dizziness, feeling "goofy," or had difficulty thinking soon after standing up from a sitting or lying position, and generates a total score ranging from 0 to 40 with higher scores representing a higher symptom burden. The treatment effect of interest was the difference from baseline in OI score of COMPASS-31. A more negative change from baseline indicates a greater improvement in OI symptoms. |
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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 |
|---|---|---|---|---|---|---|
| University of Alabama Hospital at Birmingham | Birmingham | Alabama | 35294-1152 | United States | ||
| Center for Complex Neurology, EDS & POTS |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
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.
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A total of 66 participants were screened, and 50 of these were screen failures. A total of 16 participants were randomized in the study.
This study was conducted in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | IgPro20/IgPro20 | Participants received IgPro20 during Periods 1 and 2. |
| FG001 | Placebo/IgPro20 | Participants received a volume-matched placebo during Period 1, followed by IgPro20 in Period 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period (Period 1) |
|
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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 | Apr 24, 2024 | Mar 24, 2026 |
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Period 1 (double-blind): Participant, Care Provider, Investigator, Outcomes Assessor
Period 2 (open-label): No masking
| Placebo | Biological | 2% human albumin solution administered subcutaneously as a volume-matched dose to the experimental IMP. |
|
| At Baseline and at Week 25 |
| Change From Baseline in COMPASS-31 Total Score | The COMPASS-31 was a self-reported questionnaire that measured autonomic symptoms related to six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. This questionnaire generated a weighted score ranging from 0 to 100, with higher scores representing a higher symptom burden. A COMPASS-31 score of >=40 indicated that participants had severe autonomic dysfunction. A more negative change from baseline indicates a greater improvement in autonomic symptoms. | At Baseline and at Week 25 |
| Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test | Heart rate for the standing test was measured at the end of 10 minutes in the supine position and at 1, 3, 5, 7, and 10 minutes of standing. The change in heart rate during the standing test was calculated as the difference between the average of the two highest heart rate measurements (bpm) within 10 minutes of standing and the heart rate measurement (bpm) at the end of 10 minutes in the supine position. | At Baseline and at Week 25 |
| Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE | Up to Week 45 |
| Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE | The participant data were rounded to one decimal place. | Up to Week 45 |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Up to Week 45 |
| Percentage of Participants With Clinically Significant ECG Abnormalities | Up to Week 45 |
| Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities | From Baseline up to Week 45 |
| Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities | From Baseline up to Week 45 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States |
| Arkansas Cardiology Clinic - Little Rock | Little Rock | Arkansas | 72205 | United States |
| UC San Diego Health | La Jolla | California | 92037 | United States |
| University of california Irvine | Orange | California | 92868 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Hope Research Network | Miami | Florida | 33166 | United States |
| Well Pharma Medical Research, Corp | Miami | Florida | 33173 | United States |
| Velocity Clinical Research, Savannah | Savannah | Georgia | 31406 | United States |
| LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Velocity Clinical Research, Metairie | New Orleans | Louisiana | 70119 | United States |
| Johns Hopkins Bayview Medical Center PMR | Baltimore | Maryland | 21224 | United States |
| Mass General Brigham (Massachusetts General Hospital) | Belmont | Massachusetts | 02478 | United States |
| Profound Research LLC at Millennium Affiliated Physicians | Farmington Hills | Michigan | 48334 | United States |
| Velocity Clinical Research - Lincoln | Lincoln | Nebraska | 68510 | United States |
| Dysautonomia Clinic | Buffalo | New York | 14221 | United States |
| NYU Langone Health South Shore Neurologic Associates | Patchogue | New York | 11772 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45236 | United States |
| University Hospital Cleveland Medical Center | Cleveland | Ohio | 44195 | United States |
| Hightower Clinical | Oklahoma City | Oklahoma | 73134 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Velocity Clinical Research - Union | Union | South Carolina | 29379 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UT Austin Dell Medical School | Austin | Texas | 78712 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Prolato Clinical Research Center | Houston | Texas | 77054 | United States |
| Sunbeam Clinical Research | McKinney | Texas | 75069 | United States |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| Bateman Horne Center | Salt Lake City | Utah | 84102 | United States |
| Metrodora Institute | West Valley City | Utah | 84119 | United States |
| Velocity Clinical Research - Hampton | Hampton | Virginia | 23666 | United States |
| VCU Health | Richmond | Virginia | 23219 | United States |
| Libin Cardiovascular Institute University of Calgary | Calgary | T2N 4Z6 | Canada |
| University of Alberta Hospital | Edmonton | T6G 2B7 | Canada |
| McGill University Health Centre | Québec | H4A 3J1 | Canada |
| Ciussse-Chus | Sherbrooke | J1H 5N4 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| Open-label Period (Period 2) |
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The Intention-to-Treat (ITT) analysis set included all participants in the Screened Analysis Set (SAS) who were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | IgPro20/IgPro20 | Participants received IgPro20 during Periods 1 and 2. |
| BG001 | Placebo/IgPro20 | Participants received a volume-matched placebo during Period 1, followed by IgPro20 in Period 2. |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Proportion of Participants No Longer Meeting Diagnostic Criteria of Post-COVID POTS as Measured by Standardized Standing Test (ie, No Longer Experiencing HR Increase of ≥30 Bpm, in the Absence of 20 mmHg Decrease of SBP [Orthostatic Hypotension]) | The reported data reflect the percentage of participants who no longer met the diagnostic criteria for Post-Coronavirus Disease 2019 (COVID) Postural Orthostatic Tachycardia Syndrome (POTS), as assessed by a standardized standing test (i.e., no longer experiencing a heart-rate (HR) increase of >=30 bpm in the absence of a 20 mmHg decrease in systolic blood pressure [SBP; orthostatic hypotension]), among participants evaluated at that visit. The Baseline data represent the proportion of participants who were meeting the diagnostic criteria for post-COVID POTS. | Analysis was performed on the ITT Analysis Set, which included all participants in the SAS who were randomized into the study. 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 time point. Due to early study termination, no participants in the placebo arm had available data at Week 25. | Posted | Number | Percentage of participants | At Baseline and at Week 25 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Orthostatic Intolerance (OI) Score of Composite Autonomic Symptom Score 31 (COMPASS-31) | The COMPASS-31 was a self-reported questionnaire that measures autonomic symptoms across six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. The OI domain assesses symptoms including faintness, dizziness, feeling "goofy," or had difficulty thinking soon after standing up from a sitting or lying position, and generates a total score ranging from 0 to 40 with higher scores representing a higher symptom burden. The treatment effect of interest was the difference from baseline in OI score of COMPASS-31. A more negative change from baseline indicates a greater improvement in OI symptoms. | Analysis was performed on the ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the 'N' included all participants who were evaluated for this outcome measure. The study was terminated early due to recruitment difficulties; consequently, no participants in the placebo arm had available data at Week 25. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline and at Week 25 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in COMPASS-31 Total Score | The COMPASS-31 was a self-reported questionnaire that measured autonomic symptoms related to six domains: OI, vasomotor, secretomotor, gastrointestinal (GI), bladder, and pupillomotor. This questionnaire generated a weighted score ranging from 0 to 100, with higher scores representing a higher symptom burden. A COMPASS-31 score of >=40 indicated that participants had severe autonomic dysfunction. A more negative change from baseline indicates a greater improvement in autonomic symptoms. | Analysis was performed on ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the 'N' included all participants who were evaluated for this outcome measure. The study was terminated early due to recruitment difficulties; consequently, no participants in the placebo arm had available data at Week 25. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline and at Week 25 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Heart Rate Increase Within 10 Minutes of Standing Test | Heart rate for the standing test was measured at the end of 10 minutes in the supine position and at 1, 3, 5, 7, and 10 minutes of standing. The change in heart rate during the standing test was calculated as the difference between the average of the two highest heart rate measurements (bpm) within 10 minutes of standing and the heart rate measurement (bpm) at the end of 10 minutes in the supine position. | Analysis was performed on ITT Analysis Set, which included all participants in the SAS who were randomized into the study. Here, the 'N' included all participants who were evaluated for this outcome measure. The study was terminated early due to recruitment difficulties; consequently, no participants in the placebo arm had available data at Week 25. | Posted | Mean | Standard Deviation | Beats per minute | At Baseline and at Week 25 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Event (TEAE), Related TEAE, Serious TEAE and Related Serious TEAE | Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any investigational product (IP). | Posted | Count of Participants | Participants | Up to Week 45 |
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| Secondary | Percentage of Participants With TEAE, Related TEAE, Serious TEAE and Related Serious TEAE | The participant data were rounded to one decimal place. | Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. | Posted | Number | Percentage of participants | Up to Week 45 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure. | Posted | Count of Participants | Participants | Up to Week 45 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Significant ECG Abnormalities | Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure. | Posted | Number | Percentage of participants | Up to Week 45 |
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| Secondary | Number of Participants With Change From Baseline in Clinically Significant ECG Abnormalities | Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure. | Posted | Count of Participants | Participants | From Baseline up to Week 45 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Change From Baseline in Clinically Significant ECG Abnormalities | Analysis was performed on the Safety Analysis Set, which included all participants in the ITT Analysis Set who received any IP. Here, the 'N' included all participants who were evaluated for this outcome measure. Here, the 'N' included all participants who were evaluated for this outcome measure, and the 'n', included all participants who were evaluated for this outcome measure. | Posted | Number | Percentage of participants | From Baseline up to Week 45 |
|
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Up to Week 45
Analysis was performed on the Safety Analysis Set, which included all participants in the IIT Analysis Set who received any IP. The data presented are TEAE.
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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 | IgPro20 (Double-blind Period) | Participants received IgPro20 during Double-blind period. | 0 | 11 | 0 | 11 | 10 | 11 |
| EG001 | Placebo (Double-blind Period) | Participants received a volume- matched placebo during Double-blind treatment Period. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | IgPro20 (Open-label Period) | Participants received IgPro20 during Open-label period. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site pain | General disorders | 28.0 | Systematic Assessment |
| |
| Pain | General disorders | 28.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 28.0 | Systematic Assessment |
| |
| Infusion site haemorrhage | General disorders | 28.0 | Systematic Assessment |
| |
| Infusion site swelling | General disorders | 28.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | 28.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 28.0 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | 28.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 28.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | 28.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | 28.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 28.0 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | 28.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 28.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | 28.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | 28.0 | Systematic Assessment |
| |
| Sensitive skin | Skin and subcutaneous tissue disorders | 28.0 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | 28.0 | Systematic Assessment |
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| Grip strength decreased | Investigations | 28.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 28.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 28.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | 28.0 | Systematic Assessment |
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| Major depression | Psychiatric disorders | 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 28.0 | Systematic Assessment |
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| Postural orthostatic tachycardia syndrome | Cardiac disorders | 28.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | 28.0 | Systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | 28.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | 28.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 28.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 28.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | 28.0 | Systematic Assessment |
|
The study was permanently terminated early by the sponsor because of recruitment difficulties due to stringent eligibility criteria relating to the participant's acute COVID-19 infection. Fewer than 10% of the planned number of participants were enrolled in the study and, consequently, no efficacy conclusions can be drawn due to the limited sample size and the fact that the premature discontinuation occurred at different study visits.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Disclosure Manager | CSL Behring | 1-610-878-4697 | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2025 | Mar 24, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C558471 | Hizentra |
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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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| At Week 25 |
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| Counts |
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| Participants |
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| Participants |
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