Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B.
Key Secondary Objectives:
To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IB1001 | Experimental |
| |
| nonacog alfa | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IB1001 | Biological | Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Hemorrhage Control by Treatment Regimen | Subject rating of bleed control within 6 hours of the time bleeding has stopped:
| Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (0-inf) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss During Surgery | Surgeon assessment of blood loss during the procedure using the following descriptors: less than expected, expected, or more than expected. Measure was assessed during Surgical Substudy. | During the surgical procedure |
| Hemostasis Following Surgery |
Inclusion Criteria:
Patient must be willing to give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent, make the required study visits, and follow instructions while enrolled in the study
Severe (factor IX activity ≤2 U/dL) hemophilia B subjects on demand therapy with a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern as above demonstrated prior to starting prophylaxis
Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents
Previously treated patients with a minimum of 150 exposure days to a factor IX preparation
Platelet count at least 150,000/mm3
Liver function: alanine transaminase [ALT] and aspartate transaminase [AST] ≤2 times the upper limit of the normal range
Total bilirubin ≤1.5 times the upper limit of the normal range
Renal function: serum creatinine ≤1.25 times the upper limit of the normal range
Willingness to participate in the trial for up to 12-15 months
European Union (EU), Israel, and Canada: Age of at least 12 years and body weight of ≥40 kilograms to participate in any PK Study or the Surgical Sub-study [the Surgical Sub-study does not apply to the UK]; age of at least 12 years for the prophylaxis and on demand components of the Treatment Phase and Continuation Study
United States (US): Age of at least 12 years and body weight of ≥40 kilograms to participate in any PK Study or the Surgical Sub-study; age of at least 5 years for the prophylaxis and on demand components of the Treatment Phase and Continuation Study
Hemoglobin ≥7 g/dL at the time of the blood draw
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| The Hemophilia Treatment Center of Orthopaedic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28833808 | Result | Collins PW, Quon DVK, Makris M, Chowdary P, Kempton CL, Apte SJ, Ramanan MV, Hay CRM, Drobic B, Hua Y, Babinchak TJ, Gomperts ED. Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients. Haemophilia. 2018 Jan;24(1):104-112. doi: 10.1111/hae.13324. Epub 2017 Aug 17. | |
| 22764744 |
Not provided
Not provided
Subjects could enter the study at any part and could leave at any time. Of the 77 subjects in the total study population, 32 entered during the PK part, 35 entered during the Treatment part, and 10 entered during the Surgical Substudy. Nine subjects participated only in one Part: 3 only in the PK study and 6 only in the Surgical Substudy
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PK: IB1001 First, Then Nonacog Alfa | Pharmacokinetic Study: Randomized, double-blind, cross-over study |
| FG001 | PK: Nonacog Alfa First, Then IB1001 | Pharmacokinetic Study: Randomized, double-blind, cross-over study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pharmacokinetic Study |
|
Not provided
Not provided
Not provided
Study Part 1: Randomized, double-blind, cross-over study of pharmacokinetics; Study Part 2: Non-randomized, open-label study of safety and efficacy; Surgical sub-study: Non-randomized, open-label study of safety and efficacy during major surgery
Not provided
Not provided
Study Part 1 only
|
| nonacog alfa | Biological | Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa |
|
|
| Area Under the Curve (0-72 hr) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Terminal Half-life | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Concentration (Max) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Incremental Recovery | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Mean Residence Time | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Clearance | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Volume of Distribution (Steady State) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Pre-infusion to 72 hours following infusion |
| Annualized Bleed Rate | Measure was assessed during the Treatment Study | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months |
Surgeon assessment of hemostasis at 12 and 24 hours after surgery using the following descriptors: superior, adequate, or poorly controlled. Measure was assessed during Surgical Substudy. |
| 12 and 24 hours after surgery |
| Number of Surgeries Requiring Blood Transfusions | Measure was assessed during Surgical Substudy. | During the surgical procedure |
| Los Angeles |
| California |
| 90007 |
| United States |
| Emory University School of Medicine Pediatric Hematology | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center-Pediatric Hematology Oncology | Chicago | Illinois | 60612 | United States |
| Indiana Hemophilia & Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| University of Minnesota Center for Bleeding and Clotting Disorder | Minneapolis | Minnesota | 55455 | United States |
| Hemophilia Treatment Center of Las Vegas | Las Vegas | Nevada | 89109 | United States |
| Hemophilia and Thrombosis Center | Cincinnati | Ohio | 45229 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center | Houston | Texas | 77030 | United States |
| Centre Regional de Traitement de l 'Hemophilie | Nantes | Loire-Atlantique | 44093 | France |
| Hopital Edouard Herriot | Lyon | 69437 | France |
| Sahyadri Specialty Hospital, Deccan Gymkhana | Pune | Maharashtra | 411 004 | India |
| Jehangir Clinical Development Centre | Pune | Maharashtra | 411 011 | India |
| The National Hemophilia Center-Sheba MC | Tel Litwinsky | Ramat Gan | 52621 | Israel |
| Ospedale di Careggi | Florence | I-50134 | Italy |
| University of Milan | Milan | I-20122 | Italy |
| MTZ Clinical Research | Warsaw | 02-106 | Poland |
| Royal Free Hospital | London | England | NW3 2QG | United Kingdom |
| Manchester Haemophilia Comprehensive Care Manchester Royal Infirmary | Manchester | England | M13 9WL | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | England | S102JF | United Kingdom |
| Centre for Haemostasis and Thrombosis, Basingstoke and North Hampshire Foundation Trust | Basingstoke | Hampshire | RG24 9NA | United Kingdom |
| University Hospital of Wales Health Park | Cardiff | Wales | CF4 4XN | United Kingdom |
| Martinowitz U, Shapiro A, Quon DV, Escobar M, Kempton C, Collins PW, Chowdary P, Makris M, Mannucci PM, Morfini M, Valentino LA, Gomperts E, Lee M. Pharmacokinetic properties of IB1001, an investigational recombinant factor IX, in patients with haemophilia B: repeat pharmacokinetic evaluation and sialylation analysis. Haemophilia. 2012 Nov;18(6):881-7. doi: 10.1111/j.1365-2516.2012.02897.x. Epub 2012 Jul 5. |
| FG002 | Repeat IB1001 PK | Repeat Pharmacokinetic Study: Non-randomized, open-label study |
| FG003 | IB1001 Prophylaxis | Treatment Study: Non-randomized, open-label study |
| FG004 | IB1001 On Demand | Treatment Study: Non-randomized, open-label study |
| FG005 | IB1001 Surgical Substudy | Surgical Substudy: Non-randomized, open-label study |
| COMPLETED |
|
| NOT COMPLETED |
|
| Repeat Pharmacokinetic Study |
|
| Treatment Study |
|
| Surgical Sub-study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IB1001 Safety Population | Study Population exposed to at least one infusion of IB1001. |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | 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 | Degree of Hemorrhage Control by Treatment Regimen | Subject rating of bleed control within 6 hours of the time bleeding has stopped:
| The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand. | Posted | Count of Units | Bleeding Episodes | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months | Bleeding Episodes | Bleeding Episodes |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (0-inf) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | IU*hr/dL | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (0-72 hr) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | IU*hr/dL | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Terminal Half-life | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | hours | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Concentration (Max) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | IU/dL | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Incremental Recovery | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | IU/dL per IU/kg | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Mean Residence Time | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | hours | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Clearance | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | dL/kg*hr | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Volume of Distribution (Steady State) | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. | Posted | Mean | Standard Deviation | dL/kg | Pre-infusion to 72 hours following infusion |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Annualized Bleed Rate | Measure was assessed during the Treatment Study | The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand. | Posted | Median | Inter-Quartile Range | Bleeds/year | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months |
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Blood Loss During Surgery | Surgeon assessment of blood loss during the procedure using the following descriptors: less than expected, expected, or more than expected. Measure was assessed during Surgical Substudy. | Major surgeries include synovectomy, knee or hip replacement, total tooth extraction, surgery for intracranial hemorrhage, radial head excision, arthrodesis, ankle surgery, abdominal surgery, prostatectomy, or surgery for major muscle bleed repair | Posted | Count of Units | Major surgeries | During the surgical procedure | Major surgeries | Major surgeries |
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Hemostasis Following Surgery | Surgeon assessment of hemostasis at 12 and 24 hours after surgery using the following descriptors: superior, adequate, or poorly controlled. Measure was assessed during Surgical Substudy. | Posted | Count of Units | Major surgeries | 12 and 24 hours after surgery | Major surgeries | Major surgeries |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Surgeries Requiring Blood Transfusions | Measure was assessed during Surgical Substudy. | Posted | Count of Units | Major surgeries | During the surgical procedure | Major surgeries | Major surgeries |
|
|
Not provided
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 | IB1001 Safety Population | Adverse Events were only analyzed for the IB1001 safety population; they were not collected per intervention. The safety population is defined as all subjects who received at least one dose of IB1001 in any part of the study. | 10 | 77 | 58 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | Deemed unrelated to IB1001 |
| ||
| Diverticulitis | Infections and infestations | Deemed unrelated to IB1001 |
| ||
| Skin laceration | Injury, poisoning and procedural complications | Deemed unrelated to IB1001 |
| ||
| Periprosthetic fracture | Injury, poisoning and procedural complications | Deemed unrelated to IB1001 |
| ||
| Joint injury | Injury, poisoning and procedural complications | Deemed unrelated to IB1001 |
| ||
| Limb injury | Injury, poisoning and procedural complications | Deemed unrelated to IB1001 |
| ||
| Abdominal pain | Gastrointestinal disorders | Deemed unrelated to IB1001 |
| ||
| Mental status changes | Psychiatric disorders | Deemed unrelated to IB1001 |
| ||
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | Deemed unrelated to IB1001 |
| ||
| Wound infection | Infections and infestations | Deemed unrelated to IB1001 |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Deemed unrelated to IB1001 |
| ||
| Postoperative wound infection | Infections and infestations | Deemed unrelated to IB1001 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
| |||
| Dairrhoea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Pyrexia | General disorders |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Contusion | Injury, poisoning and procedural complications |
| |||
| Limb injury | Injury, poisoning and procedural complications |
| |||
| Procedural pain | Injury, poisoning and procedural complications |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders |
| |||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Arthritis | Musculoskeletal and connective tissue disorders |
| |||
| Joint injury | Injury, poisoning and procedural complications |
| |||
| Upper respiratory tract infection | Infections and infestations |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Medexus Pharma, Inc. | 1-312-548-3125 | julissa.leon@medexus.com |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
Not provided
Not provided
| ID | Term |
|---|---|
| C579324 | IB1001 |
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided
| Unknown or Not Reported |
|
| Black or African American |
|
| Caucasian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Fair |
|
| Poor |
|
| Not Rated |
|
|
|
|
|
|
|
|
|
|
| Major surgeries |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Major surgeries |
|
|
| Major surgeries |
|
|