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A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

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ClinicalTrials.gov Identifier: NCT01426763
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : January 4, 2013
Last Update Posted : April 15, 2014
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition Hereditary Angioedema
Intervention Biological: CINRYZE with rHuPH20
Enrollment 12

Recruitment Details  
Pre-assignment Details  
Arm/Group Title SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2
Hide Arm/Group Description Subcutaneous (SC) injection of 1000 Units of CINRYZE with 20,000 Units of recombinant human hyaluronidase (rHuPH20) twice weekly for two weeks Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2 Total
Hide Arm/Group Description Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
31.5  (7.79) 33.7  (10.27) 32.6  (8.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
3
  50.0%
4
  66.7%
7
  58.3%
Male
3
  50.0%
2
  33.3%
5
  41.7%
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 18 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2
Hide Arm/Group Description:
Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
Number of subjects with adverse events 6 5
Number of subjects with injection site reactions 6 5
Number of subjects who discontinued study drug 0 0
Number of subjects who withdrew from the study 0 0
2.Secondary Outcome
Title C1 Inhibitor (C1 INH) and C4 Levels
Hide Description [Not Specified]
Time Frame 18 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Subjects With C1 INH Antibodies
Hide Description [Not Specified]
Time Frame Through 30 days after final dose
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2
Hide Arm/Group Description Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
All-Cause Mortality
SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SC CINRYZE With rHuPH20 Dose Level 1 SC CINRYZE With rHuPH20 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   5/6 (83.33%) 
General disorders     
Injection site erythema 1 [1]  5/6 (83.33%)  5/6 (83.33%) 
Injection site hemorrhage  1/6 (16.67%)  0/6 (0.00%) 
Injection site induration  0/6 (0.00%)  1/6 (16.67%) 
Injection site edema  1/6 (16.67%)  0/6 (0.00%) 
Injection site pain  4/6 (66.67%)  1/6 (16.67%) 
Injection site pruritus  1/6 (16.67%)  0/6 (0.00%) 
Injection site swelling  2/6 (33.33%)  0/6 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  1/6 (16.67%)  0/6 (0.00%) 
Urinary tract infection  0/6 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  0/6 (0.00%)  1/6 (16.67%) 
Nervous system disorders     
Headache  0/6 (0.00%)  1/6 (16.67%) 
1
Term from vocabulary, MedDRA (14.1)
[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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Chief Scientific Officer
Organization: ViroPharma
Phone: 610-458-7300
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01426763     History of Changes
Other Study ID Numbers: 0624-204
First Submitted: August 25, 2011
First Posted: August 31, 2011
Results First Submitted: November 30, 2012
Results First Posted: January 4, 2013
Last Update Posted: April 15, 2014