Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000348-17 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated early due to futility of enrolment and not for safety reasons.
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Not provided
Not provided
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This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C1-INH | Experimental | C1-esterase inhibitor |
|
| Placebo | Placebo Comparator | Excipients of C1-INH plus albumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C1-esterase inhibitor | Drug | C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Loss-of-response During Treatment Period 2 (TP2) | Loss of response is defined as 1 of the following, whichever occurs first:
| Up to 38 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-cause Allograft Failure During TP2 | Allograft failure is defined as 1 of the following:
| Up to 38 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital (at Birmingham) | Birmingham | Alabama | 35233 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33332922 | Derived | Viklicky O, Slatinska J, Novotny M, Hruba P. Developments in immunosuppression. Curr Opin Organ Transplant. 2021 Feb 1;26(1):91-96. doi: 10.1097/MOT.0000000000000844. |
Not provided
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Only 13 participants that completed Period 1 were eligible to continue to Period 2. Eligibility based on the amendment in place at the time the subject completed Period 1.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | C1-INH | C1-esterase inhibitor (CSL842) C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Open-label) |
|
Not provided
Not provided
| 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, 2020 | Nov 18, 2021 |
Not provided
Not provided
Randomized-withdrawal
Not provided
Not provided
Not provided
| Placebo | Drug | Excipients of C1-INH plus albumin |
|
| Percent of Participants With All-cause Allograft Failure During TP2 |
| Up to 38 weeks |
| Absolute Change From Baseline in Estimated Glomerular Filtration Rate at End of Treatment Period 1 (TP1) | Baseline and 13 weeks |
| Absolute Change From Baseline in Estimated Glomerular Filtration Rate at End of TP2 | Baseline and 38 weeks |
| The Rate of Change of eGFR During TP2 as Defined by the Slope of the Mean Regression of eGFR Over Time at End of TP2 | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. | Up to 38 weeks |
| Time to All-cause Allograft Failure Through the Follow up Period | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. | Up to approximately 208 weeks |
| Number of Responders at the End-of-TP1 | Responders were defined as subjects whose End-of-TP1 eGFR was ≥ 90% of baseline eGFR and ≥ 20 mL/min/1.73 m2. | Up to 13 weeks |
| Percent of Responders at the End-of-TP1 | Responders were defined as subjects whose End-of-TP1 eGFR was ≥ 90% of baseline eGFR and ≥ 20 mL/min/1.73 m2. | Up to 13 weeks |
| Proportion of Subjects Surviving Through the Follow-up Period | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. | Up to approximately 208 weeks |
| Percent of Participants With Any Adverse Event (AE) Assessed as Related to Investigational Product | Up to approximately 42 weeks after the time of first investigational product administration |
| Mean Pre-dose C1-esterase Inhibitor Functional Activity | C1-esterase Inhibitor may play a role in the prevention of antibody-mediated rejection (AMR) following kidney transplant. Low levels of C1 esterase inhibitor concentration and its functional activity may lead to AMR. Patients with AMR may go on to lose their kidney transplant and have other associated health risks. Levels of C1-esterase inhibitor functional activity in plasma is described as a percent. | Up to 13 weeks |
| Area Under the Plasma Concentration Time Curve (AUC0-t) for C1-INH Functional Activity | C1-esterase Inhibitor may play a role in the prevention of antibody-mediated rejection (AMR) following kidney transplant. Low levels of C1 esterase inhibitor concentration and its functional activity may lead to AMR. Patients with AMR may go on to lose their kidney transplant and have other associated health risks. Levels of C1-esterase inhibitor functional activity is described as a percent. | Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1 |
| Time to Maximum Plasma Concentration (Tmax) for C1-INH Functional Activity | Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1 |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| California Pacific | San Francisco | California | 94115 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
| Brigham & Women's | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic (Rochester) | Rochester | Minnesota | 55905 | United States |
| St. Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| NYU | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705-2281 | United States |
| Universitair Ziekenhuis Gasthuisberg | Leuven | 3000 | Belgium |
| CHU de Bordeaux. Hôpital Pellegrin | Bordeaux | 33000 | France |
| CHU de Grenoble - Hôpital Michalon | Grenoble | 38043 | France |
| Centre Regional Hospitalier Universitaire de Lille | Lille | 59000 | France |
| Hospital Edouard Herriot Lyon | Lyon | 69003 | France |
| Hopital saint Louis Paris | Paris | 75010 | France |
| Necker Hospital | Paris | 75743 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| Charite Berline | Berlin | 10117 | Germany |
| Leiden University Medical Center | Leiden | 2300 | Netherlands |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Guy's Hospital | London | SE19RT | United Kingdom |
Excipients of C1-INH plus albumin
Placebo: Excipients of C1-INH plus albumin
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 (Randomized, Blinded) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | C1-INH | C1-esterase inhibitor (CSL842) C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| 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 | Percent of Participants With Loss-of-response During Treatment Period 2 (TP2) | Loss of response is defined as 1 of the following, whichever occurs first:
| Modified Intent-to-Treat Analysis Set (mITT) - All subjects randomized under the original protocol and under all protocol amendments were included in this population except the subjects randomized prior to Amendment 3 who did not satisfy the responder criteria updated in Amendment 3. | Posted | Number | percentage of participants | Up to 38 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With All-cause Allograft Failure During TP2 | Allograft failure is defined as 1 of the following:
| mITT | Posted | Number | number of participants | Up to 38 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With All-cause Allograft Failure During TP2 | mITT | Posted | Number | percentage of participants | Up to 38 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Estimated Glomerular Filtration Rate at End of Treatment Period 1 (TP1) | The Run-in Safety (RiS) analysis set comprised all subjects who received at least 1 dose of C1-INH during TP1. | Posted | Median | Full Range | mL/min/1.73m^2 | Baseline and 13 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in Estimated Glomerular Filtration Rate at End of TP2 | mITT | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Baseline and 38 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Rate of Change of eGFR During TP2 as Defined by the Slope of the Mean Regression of eGFR Over Time at End of TP2 | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. Due to study termination, data was not collected for this endpoint. | Posted | Up to 38 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Time to All-cause Allograft Failure Through the Follow up Period | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. Due to study termination, data was not collected for this endpoint. | Posted | Up to approximately 208 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Responders at the End-of-TP1 | Responders were defined as subjects whose End-of-TP1 eGFR was ≥ 90% of baseline eGFR and ≥ 20 mL/min/1.73 m2. | RiS | Posted | Number | participants | Up to 13 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Responders at the End-of-TP1 | Responders were defined as subjects whose End-of-TP1 eGFR was ≥ 90% of baseline eGFR and ≥ 20 mL/min/1.73 m2. | RiS | Posted | Number | percentage of responders | Up to 13 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects Surviving Through the Follow-up Period | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. | The Sponsor terminated the study due to futility of enrolment. Because of the study termination, limited efficacy results are presented in this report. Due to study termination, data was not collected for this endpoint. | Posted | Up to approximately 208 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Any Adverse Event (AE) Assessed as Related to Investigational Product | RiS and RWS [The Randomized Withdrawal Safety (RWS) analysis set included all subjects in the ITT analysis set who received at least 1 dose of the investigational product after randomization during TP2] | Posted | Number | percentage of participants | Up to approximately 42 weeks after the time of first investigational product administration |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Pre-dose C1-esterase Inhibitor Functional Activity | C1-esterase Inhibitor may play a role in the prevention of antibody-mediated rejection (AMR) following kidney transplant. Low levels of C1 esterase inhibitor concentration and its functional activity may lead to AMR. Patients with AMR may go on to lose their kidney transplant and have other associated health risks. Levels of C1-esterase inhibitor functional activity in plasma is described as a percent. | The pharmacokinetic analysis set (PK) comprised all subjects who consented to provide rich PK sampling, who received ≥ 1 dose of C1-INH, and who had ≥ 1 measurable level of C1-INH functional activity. (some participants had missing data) or C1-INH antigen concentration. | Posted | Mean | Standard Deviation | percent functional activity | Up to 13 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Time Curve (AUC0-t) for C1-INH Functional Activity | C1-esterase Inhibitor may play a role in the prevention of antibody-mediated rejection (AMR) following kidney transplant. Low levels of C1 esterase inhibitor concentration and its functional activity may lead to AMR. Patients with AMR may go on to lose their kidney transplant and have other associated health risks. Levels of C1-esterase inhibitor functional activity is described as a percent. | PK (some participants had missing data) | Posted | Mean | Standard Deviation | hours*percent functional activity | Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration (Tmax) for C1-INH Functional Activity | PK (some participants had missing data) | Posted | Mean | Standard Deviation | hours | Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1 |
|
|
Up to 42 weeks per participant
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C1-INH (Period 1) | C1-esterase inhibitor (CSL842) C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg | 0 | 63 | 25 | 63 | 46 | 63 |
| EG001 | C1-INH (Period 2) | C1-esterase inhibitor (CSL842) C1-esterase inhibitor: C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution administered at a dose of 60 IU/kg | 0 | 7 | 1 | 7 | 4 | 7 |
| EG002 | Placebo (Period 2) | Excipients of C1-INH plus albumin Placebo: Excipients of C1-INH plus albumin | 1 | 6 | 3 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Perinephric collection | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Refractory cytopenia with unilineage dysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dermatitis papillaris capillitii | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Trichomoniasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
The Sponsor terminated the study due to futility of enrolment. Because of the study termination, there are limitations in interpreting analyses and efficacy results based on small numbers of subjects. No subject reached the 48-month follow-up endpoint.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 610-878-4000 | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2020 | Nov 18, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D050718 | Complement C1 Inhibitor Protein |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003169 | Complement Inactivator Proteins |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Participants |
|
|
|
|
| Title | Denominators | Categories |
|---|
| Day 10 |
|
| ||||
| Day 77 |
|
|