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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001032-11 | EudraCT Number |
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The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).
This is a Phase 2, uncontrolled, 3-stage, ascending-dose-escalation study in patients with 1 of 3 forms of TMA: atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell transplant - associated TMA (HSCT-associated TMA). In Stage 1 of the study, OMS721 was administered to 3 cohorts, with dose escalation by cohort to identify the optimal dosing regimen. In Stage 2, the dose selected in the first stage was administered to expanded cohorts of patients with distinct etiologies (aHUS alone in 1 cohort and TTP or HSCT-TMA in the other cohort). Patients completing Stage 2 were eligible for continued treatment in Stage 3 if they tolerated OMS721 treatment and derived clinical benefit. Enrollment in the study has been completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMS721 low dose | Experimental | Administration of OMS721 at a low dose |
|
| OMS721 medium dose | Experimental | Administration of OMS721 at a medium dose |
|
| OMS721 high dose | Experimental | Administration of OMS721 at a high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMS721 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs. | Day 1 to 37 days after end of treatment, approximately up to 31 weeks. |
| Number of Participants With HSCT-TMA Who Respond to OMS721 | Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status | Day 1 to up to 2 years following the first dose of OMS721 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With HSCT-TMA Treated With OMS721: 100-day Survival | Number of participants alive from the date of TMA diagnosis | Study Day of HSCT-TMA diagnosis to 100 days later |
| Participants With HSCT-TMA Treated With OMS721: Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omeros Investigational Site | Duarte | California | 91010 | United States | ||
| Omeros Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35439028 | Derived | Khaled SK, Claes K, Goh YT, Kwong YL, Leung N, Mendrek W, Nakamura R, Sathar J, Ng E, Nangia N, Whitaker S, Rambaldi A; OMS721-TMA-001 Study Group Members. Narsoplimab, a Mannan-Binding Lectin-Associated Serine Protease-2 Inhibitor, for the Treatment of Adult Hematopoietic Stem-Cell Transplantation-Associated Thrombotic Microangiopathy. J Clin Oncol. 2022 Aug 1;40(22):2447-2457. doi: 10.1200/JCO.21.02389. Epub 2022 Apr 19. | |
| 33783815 |
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| ID | Title | Description |
|---|---|---|
| FG000 | OMS721 Low Dose | Administration of OMS721 at a low dose OMS721 |
| FG001 | OMS721 Medium Dose | Administration of OMS721 at a medium dose OMS721 |
| 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 | Jun 1, 2020 | Feb 15, 2024 |
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Survival days from the day of TMA diagnosis
| Study Day of HSCT-TMA diagnosis to up to 2 years following first dose of OMS721 |
| Participants With HSCT-TMA Treated With OMS721: Duration of Response | Number of days from the first response date to the first relapse date | Study Day 1 to up to 2 years following first dose of OMS721 |
| Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion | Number of participants with absence of platelet transfusions | Study Day -14 to 4 weeks following the last platelet transfusion |
| Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion | Number of participants with absence of RBC transfusions | Study Day -14 to 4 weeks following the last RBC transfusion |
| Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Platelet Count | Changes from baseline in Platelet count | Study Day 1 to Day 97, approximately 13 weeks |
| Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | PK parameters including clearance rate | Pre-dose and up to 204 days post-dose |
| Participants With HSCT-TMA (ADA) | Presence of ADA response. Immunogenicity of multiple-dose administration of OMS721 in subjects with TMA | Pre-dose and up to 204 days post-dose |
| Participants With HSCT-TMA Treated With OMS721: Change From Baseline in LDH | Changes from baseline in LDH | Study Day 1 to Day 97, approximately 13 weeks |
| Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Creatine | Changes from baseline in Creatine | Study Day 1 to Day 97, approximately 13 weeks |
| Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Haptoglobin | Changes from baseline in Haptoglobin | Study Day 1 to Day 97, approximately 13 weeks |
| Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Hemoglobin | Changes from baseline in Hemoglobin | Study Day 1 to Day 97, approximately 13 weeks |
| Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | PK parameters Apparent volume of the central compartment (V1) | Pre-dose and up to 204 days post-dose |
| Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | PK parameters Concentration of OMS721 that achieves half maximum elimination rate (KM) (ug/mL) | Pre-dose and up to 204 days post-dose |
| Participants With HSCT-TMA: Pharmacodynamics (PD) | PD measure is expressed as percentage inhibition of C4d to assess ex-vivo lectin pathway activation | Pre-dose and up to 204 days post-dose |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Omeros Investigational Site | New York | New York | 10065 | United States |
| Omeros Investigational Site | Durham | North Carolina | 27710 | United States |
| Omeros Investigational Site | Madison | Wisconsin | 53792 | United States |
| Omeros Investigational Site | Brussels | Belgium |
| Omeros Investigational Site | Leuven | Belgium |
| Omeros Investigational Site | Liège | Belgium |
| Omeros Investigational Site | Sofia | Bulgaria |
| Omeros Investigational Site | Shatin | Hong Kong |
| Omeros Investigational Site | Bergamo | Italy |
| Omeros Investigational Site | Vilnius | Lithuania |
| Omeros Investigational Site | Selangan | Malaysia |
| Omeros Investigational Site | Christchurch | New Zealand |
| Omeros Investigational Site | Katowice | Poland |
| Omeros Investigational Site | Krakow | Poland |
| Omeros Investigational Site | Lodz | Poland |
| Omeros Investigational Site | Warsaw | Poland |
| Omeros Investigational Site | Singapore | Singapore |
| Omeros Investigational Site | Taichung | Taiwan |
| Omeros Investigational Site | Taipei | Taiwan |
| Omeros Investigational Site | Ban Pathumwan | Thailand |
| Omeros Investigational Site | Bangkok | Thailand |
| Omeros Investigational Site | Pathum Thani | Thailand |
| Derived |
| Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2. |
| FG002 | OMS721 High Dose | Administration of OMS721 at a high dose OMS721 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OMS721 Low Dose | Administration of OMS721 at a low dose OMS721 |
| BG001 | OMS721 Medium Dose | Administration of OMS721 at a medium dose OMS721 |
| BG002 | OMS721 High Dose | Administration of OMS721 at a high dose OMS721 |
| BG003 | 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 |
| ||||||||||||||||
| 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 | Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA | Incidence of treatment-emergent adverse events (AEs): clinically significant changes in vital signs, ECG, and laboratory tests were reported as AEs. | 28 participants entered the study with a diagnosis of HSCT-TMA; all participants were in the High Dose Arm | Posted | Count of Participants | Participants | Day 1 to 37 days after end of treatment, approximately up to 31 weeks. |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With HSCT-TMA Who Respond to OMS721 | Response defined as: Improvement in TMA laboratory markers of platelet count and lactate dehydrogenase (LDH) and improvement in clinical status | Only subjects with HSCT-TMA were analyzed; 28 subjects with HSCT were in the Full Analysis Set (FAS) | Posted | Count of Participants | Participants | Day 1 to up to 2 years following the first dose of OMS721 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: 100-day Survival | Number of participants alive from the date of TMA diagnosis | Only participants with HSCT-TMA were analyzed; all 28 HSCT-TMA participants were in the OMS721 high dose arm | Posted | Count of Participants | Participants | Study Day of HSCT-TMA diagnosis to 100 days later |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Overall Survival | Survival days from the day of TMA diagnosis | Only participants with HSCT-TMA were analyzed; all 28 HSCT-TMA participants were in the OMS721 high dose arm | Posted | Median | 95% Confidence Interval | days | Study Day of HSCT-TMA diagnosis to up to 2 years following first dose of OMS721 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Duration of Response | Number of days from the first response date to the first relapse date | Only participants with HSCT-TMA and responded to OMS721 were analyzed. | Posted | Median | 95% Confidence Interval | Days | Study Day 1 to up to 2 years following first dose of OMS721 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Freedom From Platelet Transfusion | Number of participants with absence of platelet transfusions | Only participants with HSCT-TMA who were receiving platelet transfusions were analyzed; all were in the OMS721 high dose arm | Posted | Count of Participants | Participants | Study Day -14 to 4 weeks following the last platelet transfusion |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Freedom From Red Blood Cell (RBC) Transfusion | Number of participants with absence of RBC transfusions | Only participants with HSCT-TMA who were receiving RBC transfusions were analyzed; all were in the OMS721 high dose arm | Posted | Count of Participants | Participants | Study Day -14 to 4 weeks following the last RBC transfusion |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Platelet Count | Changes from baseline in Platelet count | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | Posted | Mean | 95% Confidence Interval | 10^9 cells per liter | Study Day 1 to Day 97, approximately 13 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | PK parameters including clearance rate | PK parameters were reported for all groups combined. | Posted | Mean | Standard Deviation | L/H | Pre-dose and up to 204 days post-dose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA (ADA) | Presence of ADA response. Immunogenicity of multiple-dose administration of OMS721 in subjects with TMA | Posted | Count of Participants | Participants | Pre-dose and up to 204 days post-dose |
| |||||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in LDH | Changes from baseline in LDH | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | Posted | Mean | 95% Confidence Interval | U/L | Study Day 1 to Day 97, approximately 13 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Creatine | Changes from baseline in Creatine | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | Posted | Mean | 95% Confidence Interval | mg/dL | Study Day 1 to Day 97, approximately 13 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Haptoglobin | Changes from baseline in Haptoglobin | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | Posted | Mean | 95% Confidence Interval | mg/dL | Study Day 1 to Day 97, approximately 13 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA Treated With OMS721: Change From Baseline in Hemoglobin | Changes from baseline in Hemoglobin | Only participants with HSCT-TMA were analyzed; all were in the OMS721 high dose arm | Posted | Mean | 95% Confidence Interval | g/dL | Study Day 1 to Day 97, approximately 13 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | PK parameters Apparent volume of the central compartment (V1) | PK parameters were reported for all groups combined. | Posted | Mean | Standard Deviation | L | Pre-dose and up to 204 days post-dose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA: Pharmacokinetics (PK) of Multiple-dose Administration of OMS721 | PK parameters Concentration of OMS721 that achieves half maximum elimination rate (KM) (ug/mL) | PK parameters were reported for all groups combined. | Posted | Mean | Standard Deviation | ug/mL | Pre-dose and up to 204 days post-dose |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Participants With HSCT-TMA: Pharmacodynamics (PD) | PD measure is expressed as percentage inhibition of C4d to assess ex-vivo lectin pathway activation | PD was analyzed only in HSCT-TMA participants | Posted | Mean | Standard Deviation | Percentage | Pre-dose and up to 204 days post-dose |
|
|
The Adverse Event period of time was from the date of Consent to 2 years after the first dose of study drug.
AEs are assessed throughout the study up to 2 years.
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 | HSCT-TMA-001 High Dose (N=28) | 28 participants entered the study with a diagnosis of HSCT-TMA | 16 | 28 | 17 | 28 | 27 | 28 |
| EG001 | aHUS OMS721-TMA-001 Low Dose | Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 3 patients with aHUS | 0 | 3 | 2 | 3 | 2 | 3 |
| EG002 | aHUS OMS721-TMA-001 Medium Dose | Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 2 patients with aHUS | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | aHUS OMS721-TMA-001 High Dose | Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported for 20 patients with aHUS | 3 | 20 | 12 | 20 | 19 | 20 |
| EG004 | TTP OMS721-TMA-001 Medium Dose | Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported by 1 patients with TTP | 0 | 1 | 0 | 1 | 0 | 1 |
| EG005 | TTP OMS721-TMA-001 High Dose | Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term reported by 4 patients with TTP | 0 | 4 | 2 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAE by System Organ | Infections and infestations | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Blood and lymphatic system disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Immune system disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Metabolism and nutrition disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Psychiatric disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Nervous system disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Cardiac disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Vascular disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Gastrointestinal disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Hepatobiliary disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Renal and urinary disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | General disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Injury, poisoning and procedural complications | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Musculoskeletal and connective tissue disorders | MedDra (22) | Systematic Assessment |
| |
| SAE by System Organ | Respiratory, thoracic and mediastinal disorders | MedDra (22) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE by System Organ | Infections and infestations | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Blood and lymphatic system disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Immune system disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Endocrine disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Metabolism and nutrition disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Psychiatric disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Nervous system disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Eye disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Cardiac disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Vascular disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Respiratory, thoracic and mediastinal disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Gastrointestinal disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Hepatobiliary disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Skin and subcutaneous tissue disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Musculoskeletal and connective tissue disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Renal and urinary disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | General disorders | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Investigations | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Injury, poisoning and procedural complications | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Surgical and medical procedures | MedDra (22) | Systematic Assessment |
| |
| AE by System Organ | Reproductive system and breast disorders | MedDra (22) | Systematic Assessment | Dysmenorrhoea |
|
| AE by System Organ | Ear and labyrinth disorders | MedDra (22) | Systematic Assessment | Vertigo |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Omeros Corporation | (206) 676-5000 | ctinfo@omeros.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2020 | Feb 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D057049 | Thrombotic Microangiopathies |
| D065766 | Atypical Hemolytic Uremic Syndrome |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D006463 | Hemolytic-Uremic Syndrome |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718989 | narsoplimab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| OG004 |
| OMS721-TMA-001 aHUS Medium Dose |
2 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS |
| OG005 | OMS721-TMA-001 aHUS High Dose | 20 Patients Incidence of Treatment-Emergent Adverse Events Leading to Study Discontinuation by System Organ Class and Preferred Term for aHUS |
|
|
|
|
|
|
| Title | Denominators | Categories |
|---|
| Apparent volume of the central compartment (V1) |
| |||||
| Apparent volume of the peripheral compartment (V2) |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline inhibition ex vivo lectin-mediated C4d Formation % |
| |||||
| Maximum inhibition ex vivo lectin-mediated Cd4 Formation % |
|