drugset / Trial / NCT01756157
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
RandomizedCrossoverQuadruple-blindPrevention
Summary
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.
Timeline
- Start
- 2013-02-04
- Primary completion
- 2013-09-13
- Completion
- 2013-09-13
Publications
- Results Riedl MA, Lumry WR, Li HH, Banerji A, Bernstein JA, Ba M, Bjrkander J, Magerl M, Maurer M, Rockich K, Chen H, Schranz J. Subcutaneous administration of human C1 inhibitor with recombinant human hyaluronidase in patients with hereditary angioedema. Allergy Asthma Proc. 2016 Nov;37(6):489-500. doi: 10.2500/aap.2016.37.4006.
- Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CINRYZE | Protein / enzyme biologic | 1000 iu | Subcutaneous |
| Subject | CINRYZE | Protein / enzyme biologic | 2000 iu | Subcutaneous |
| Subject | rHuPH20 | Protein / enzyme biologic | 24000 iu | Subcutaneous |
| Subject | rHuPH20 | Protein / enzyme biologic | 48000 iu | Subcutaneous |