Phase 2
Completed N=12
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
Source: ClinicalTrials.gov NCT01426763 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: 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 — 6; 5; 6; 5 participants
Summary
The objectives of the study are to:
1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497)
2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20
3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
6; 5; 6; 5; 0; 0 | — |
| SECONDARY Mean Change C1 Inhibitor (C1INH) |
0.0248; 0.00483; 0.0273; 0.00383; 0.0302; 0.008 | — |
| SECONDARY Mean Change C4 Compliment |
9.00; 13.3; 11.0; 10.3; 11.3; 11.0 | — |
| SECONDARY Number of Subjects With C1 INH Antibodies |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
To be eligible for this protocol, a subject must:
- Provide informed consent/assent, as appropriate.
- Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study.
- During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
- Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.
Exclusion Criteria
To be eligible for this protocol, a subject must not:
- Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
- Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
- Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
- If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
- Have a history of abnormal blood clotting.
- Have a history of allergic reaction to products containing C1 INH or other blood products.
- Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
- Be pregnant or breastfeeding.
- Have received an investigational study drug within 30 days prior to the first dose of study drug.
Data sourced from ClinicalTrials.gov (NCT01426763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.