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| ID | Type | Description | Link |
|---|---|---|---|
| SPD616-204 | Other Identifier | Sponsor |
Not provided
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| Name | Class |
|---|---|
| Halozyme Therapeutics | INDUSTRY |
Not provided
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The objectives of the study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC CINRYZE with rHuPH20 Dose Level 1 | Experimental | Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks |
|
| SC CINRYZE with rHuPH20 Dose Level 2 | Experimental | Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CINRYZE with rHuPH20 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | 18 days |
| 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 |
| Mean Change C4 Compliment |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ViroPharma Investigational Site | Scottsdale | Arizona | 85251 | United States | ||
| ViroPharma Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks |
| FG001 | SC CINRYZE With rHuPH20 Dose Level 2 | SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks |
| BG001 | SC CINRYZE With rHuPH20 Dose Level 2 |
| 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 Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study | Posted | Number | participants | 18 days |
|
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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 | Subcutaneous (SC) CINRYZE With Recombinant Human Hyaluronidase ph20 (rHuPH20) Dose Level 1 | SC injection of 1000 Units of CINRYZE with ~20,000 Units of rHuPH20 twice weekly for two weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (14.1) | Two subjects (one at each dose level) each reported two events of severe injection site erythema; all other adverse events reported in the study were of mild or moderate intensity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C469952 | SERPING1 protein, human |
| D050718 | Complement C1 Inhibitor Protein |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
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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 |
| Number of Subjects With C1 INH Antibodies | Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4) |
| Walnut Creek |
| California |
| 94598 |
| United States |
| ViroPharma Investigational Site | Atlanta | Georgia | 30342 | United States |
| ViroPharma Investigational Site | Dallas | Texas | 75231 | United States |
SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | g/L | 18 days |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/L | 18 days |
|
|
|
| Secondary | Number of Subjects With C1 INH Antibodies | Posted | Number | Participants | Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4) |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | SC CINRYZE With rHuPH20 Dose Level 2 | SC injection of 2000 Units of CINRYZE with ~40,000 Units of rHuPH20 twice weekly for two weeks | 0 | 6 | 5 | 6 |
|
| Injection site hemorrhage | General disorders | MedDRA (14.1) |
|
| Injection site induration | General disorders | MedDRA (14.1) |
|
| Injection site edema | General disorders | MedDRA (14.1) |
|
| Injection site pain | General disorders | MedDRA (14.1) |
|
| Injection site pruritus | General disorders | MedDRA (14.1) |
|
| Injection site swelling | General disorders | MedDRA (14.1) |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) |
|
| Headache | Nervous system disorders | MedDRA (14.1) |
|
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 |
| 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 |
| 2 h post Dose 1 |
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| 3 h post Dose 1 |
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| 4 h post Dose 1 |
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| 6 h post Dose 1 |
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| 8 h post Dose 1 |
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| 24 h post Dose 1 |
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| 48 h post Dose 1 |
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| Pre-Dose 2 |
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| 1 h post Dose 2 |
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| 120 h post Dose 1 |
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| Pre-Dose 3 |
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| 1 h post Dose 3 |
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| Pre-Dose 4 |
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| 1 h post Dose 4 |
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| 2 h post Dose 4 |
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| 3 h post Dose 4 |
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| 4 h post Dose 4 |
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| 6 h post Dose 4 |
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| 8 h post Dose 4 |
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| 24 h post Dose 4 |
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| 48 h post Dose 4 |
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| 72 h post Dose 4 |
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| 120 h post Dose 4 |
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| 168 h post Dose 4 |
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| 2 h post Dose 1 |
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| 3 h post Dose 1 |
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| 4 h post Dose 1 |
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| 6 h post Dose 1 |
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| 8 h post Dose 1 |
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| 24 h post Dose 1 |
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| 48 h post Dose 1 |
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| Pre-Dose 2 |
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| 1 h post Dose 2 |
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| 120 h post Dose 1 |
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| Pre-Dose 3 |
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| 1 h post Dose 3 |
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| Pre-Dose 4 |
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| 1 h post Dose 4 |
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| 8 h post Dose 4 |
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| 24 h post Dose 4 |
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| 48 h post Dose 4 |
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| 72 h post Dose 4 |
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| 120 h post Dose 4 |
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| 168 h post Dose 4 |
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| 30 (±2) days after the last dose of study drug (Dose 4) |
|