Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SPD616-200 | Other Identifier | Sponsor |
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
The objectives of the study are to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV CINRYZE First, Then SC CINRYZE Dose 1 | Experimental |
| |
| IV CINRYZE First, Then SC CINRYZE Dose 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CINRYZE | Biological | C1 esterase inhibitor (human) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | 18 days in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change C1 Inhibitor (C1INH) | Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. | 18 days in each treatment period |
Not provided
Inclusion Criteria:
To be eligible for this protocol, a subject must:
Exclusion Criteria:
To be eligible for this protocol, a subject must not:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy, Asthma and Immunology Associates | Scottsdale | Arizona | 85251 | United States | ||
| Allergy and Asthma Clinical Research, Inc. |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IV CINRYZE First, Then SC CINRYZE Dose 1 | Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks. |
| FG001 | IV CINRYZE First, Then SC CINRYZE Dose 2 | Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intravenous CINRYZE |
| |||||||||||||
| Subcutaneous CINRYZE |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IV CINRYZE First, Then SC CINRYZE Dose 1 | Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Safety Analysis Set | Posted | Number | Participants | 18 days in each treatment period |
|
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 | Intravenous (IV) CINRYZE | 1000 Units of IV CYNRYZE twice weekly for two weeks |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (14.0) | 39% mild, 51% moderate, 10% severe |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
Not provided
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C469952 | SERPING1 protein, human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mean Change C4 Compliment |
Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. |
| 18 days in each treatment period |
| Number of Participants With C1 Inhibitor (INH) Antibodies | 18 days in each treatment period |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Family Allergy and Asthma Center | Atlanta | Georgia | 30342 | United States |
| Institute for Asthma and Allergy | Chevy Chase | Maryland | 20815 | United States |
| Allergy, Asthma and Dermatology Research Center | Lake Oswego | Oregon | 97035 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Marycliff Allergy Specialists | Spokane | Washington | 99204 | United States |
| NOT COMPLETED |
|
| IV CINRYZE First, Then SC CINRYZE Dose 2 |
Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
2000 Units of SC CINRYZE twice weekly for two weeks
|
|
| Secondary | Mean Change C1 Inhibitor (C1INH) | Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. | Intent to Treat Population | Posted | Mean | Standard Deviation | g/L | 18 days in each treatment period |
|
|
|
| Secondary | Mean Change C4 Compliment | Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. | Intent to Treat Population | Posted | Mean | Standard Deviation | mg/L | 18 days in each treatment period |
|
|
|
| Secondary | Number of Participants With C1 Inhibitor (INH) Antibodies | Posted | Number | Participants | 18 days in each treatment period |
|
|
|
| 0 |
| 26 |
| 8 |
| 26 |
| EG001 | Subcutaneous (SC) CINRYZE Dose 1 | 1000 Units of SC CINRYZE twice weekly for two weeks | 0 | 13 | 10 | 13 |
| EG002 | SC CINRYZE Dose 2 | 2000 Units of SC CINRYZE twice weekly for two weeks | 0 | 12 | 11 | 12 |
| Hereditary angioedema | Congenital, familial and genetic disorders | MedDRA (14.0) | 64% mild, 27% moderate, 9% severe |
|
| Injection site erythema | General disorders | MedDRA (14.0) | 75% mild, 25% moderate |
|
| Headache | Nervous system disorders | MedDRA (14.0) | 25% mild, 75% moderate |
|
| Injection site hematoma | General disorders | MedDRA (14.0) | 100% mild |
|
| Injection site pruritus | General disorders | MedDRA (14.0) | 100% mild |
|
| Acne cystic | Skin and subcutaneous tissue disorders | MedDRA (14.0) | 50% mild, 50% moderate |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | 50% mild, 50% moderate |
|
| Injection site swelling | General disorders | MedDRA (14.0) | 100% mild |
|
Clinical Study Agreement. Most restrictive provision - PI will not publish results until after first of: multicenter publication is published or 24 months from study end. Thereafter, PI may publish his results. PI must provide copy of proposed publication to Sponsor for pre-review. If Sponsor requests, PI must delete Sponsor confidential information before publication and/or delay publication for 60 days so Sponsor can file for patents or take other action to protect its patent rights.
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
|
| 3 h post Dose 1 |
|
| 4 h post Dose 1 |
|
| 6 h post Dose 1 |
|
| 8 h post Dose 1 |
|
| 24 h post Dose 1 |
|
| 48 h post Dose 1 |
|
| Pre-Dose 2 |
|
| 1 h post Dose 2 |
|
| 120 h post Dose 1 |
|
| Pre-Dose 3 |
|
| 1 h post Dose 3 |
|
| Pre-Dose 4 |
|
| 1 h post Dose 4 |
|
| 2 h post Dose 4 |
|
| 3 h post Dose 4 |
|
| 4 h post Dose 4 |
|
| 6 h post Dose 4 |
|
| 8 h post Dose 4 |
|
| 24 h post Dose 4 |
|
| 48 h post Dose 4 |
|
| 72 h post Dose 4 |
|
| 120 h post Dose 4 |
|
| 168 h post Dose 4 |
|
|
| 3 h post Dose 1 |
|
| 4 h post Dose 1 |
|
| 6 h post Dose 1 |
|
| 8 h post Dose 1 |
|
| 24 h post Dose 1 |
|
| 48 h post Dose 1 |
|
| Pre-Dose 2 |
|
| 1 h post Dose 2 |
|
| 120 h post Dose 1 |
|
| Pre-Dose 3 |
|
| 1 h post Dose 3 |
|
| Pre-Dose 4 |
|
| 1 h post Dose 4 |
|
| 2 h post Dose 4 |
|
| 3 h post Dose 4 |
|
| 4 h post Dose 4 |
|
| 6 h post Dose 4 |
|
| 8 h post Dose 4 |
|
| 24 h post Dose 4 |
|
| 48 h post Dose 4 |
|
| 72 h post Dose 4 |
|
| 120 h post Dose 4 |
|
| 168 h post Dose 4 |
|