ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01095497
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : March 8, 2012
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Hereditary Angioedema
Intervention Biological: CINRYZE
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV CINRYZE First, Then SC CINRYZE Dose 1 IV CINRYZE First, Then SC CINRYZE Dose 2
Hide Arm/Group Description 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. 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.
Period Title: Intravenous CINRYZE
Started 14 12
Completed 13 12
Not Completed 1 0
Period Title: Subcutaneous CINRYZE
Started 13 12
Completed 12 12
Not Completed 1 0
Arm/Group Title IV CINRYZE First, Then SC CINRYZE Dose 1 IV CINRYZE First, Then SC CINRYZE Dose 2 Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 14 12 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
28.6  (12.70) 37.3  (15.92) 32.7  (14.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
7
  50.0%
8
  66.7%
15
  57.7%
Male
7
  50.0%
4
  33.3%
11
  42.3%
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 in each treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV CINRYZE SC CINRYZE Dose 1 SC CINRYZE Dose 2
Hide Arm/Group Description:
1000 Units of IV CINRYZE twice weekly for two weeks
1000 Units of SC CINRYZE twice weekly for two weeks
2000 Units of SC CINRYZE twice weekly for two weeks
Overall Number of Participants Analyzed 26 13 12
Measure Type: Number
Unit of Measure: Participants
Number of subjects with adverse events 12 10 11
Number of subjects with injection site reactions 1 10 11
Number of subjects who discontinued study drug 1 0 0
Number of subjects who withdrew from the study 1 1 0
2.Secondary Outcome
Title C1 Inhibitor (C1INH) and C4 Levels
Hide Description [Not Specified]
Time Frame 18 days in each treatment period
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Number of Subjects With C1INH Antibodies
Hide Description [Not Specified]
Time Frame 18 days in each treatment period
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV CINRYZE SC CINRYZE Dose 1 SC CINRYZE Dose 2
Hide Arm/Group Description 1000 Units of IV CINRYZE twice weekly for two weeks 1000 Units of SC CINRYZE twice weekly for two weeks 2000 Units of SC CINRYZE twice weekly for two weeks
All-Cause Mortality
IV CINRYZE SC CINRYZE Dose 1 SC CINRYZE Dose 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV CINRYZE SC CINRYZE Dose 1 SC CINRYZE Dose 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IV CINRYZE SC CINRYZE Dose 1 SC CINRYZE Dose 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/26 (30.77%)   10/13 (76.92%)   11/12 (91.67%) 
Congenital, familial and genetic disorders       
Hereditary angioedema 1 [1]  5/26 (19.23%)  2/13 (15.38%)  0/12 (0.00%) 
Gastrointestinal disorders       
Diarrhea 1 [2]  1/26 (3.85%)  1/13 (7.69%)  0/12 (0.00%) 
General disorders       
Injection site pain 1 [3]  0/26 (0.00%)  10/13 (76.92%)  8/12 (66.67%) 
Injection site erythema 1 [4]  0/26 (0.00%)  4/13 (30.77%)  2/12 (16.67%) 
Injection site hematoma 1 [5]  0/26 (0.00%)  1/13 (7.69%)  2/12 (16.67%) 
Injection site pruritus 1 [5]  0/26 (0.00%)  2/13 (15.38%)  1/12 (8.33%) 
Injection site swelling 1 [5]  0/26 (0.00%)  1/13 (7.69%)  1/12 (8.33%) 
Nervous system disorders       
Headache 1 [6]  1/26 (3.85%)  1/13 (7.69%)  2/12 (16.67%) 
Skin and subcutaneous tissue disorders       
Acne cystic 1 [2]  1/26 (3.85%)  0/13 (0.00%)  1/12 (8.33%) 
1
Term from vocabulary, MedDRA (14.0)
[1]
64% mild, 27% moderate, 9% severe
[2]
50% mild, 50% moderate
[3]
39% mild, 51% moderate, 10% severe
[4]
75% mild, 25% moderate
[5]
100% mild
[6]
25% mild, 75% moderate
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: NCT01095497     History of Changes
Other Study ID Numbers: 0624-200
First Submitted: February 22, 2010
First Posted: March 30, 2010
Results First Submitted: December 23, 2011
Results First Posted: March 8, 2012
Last Update Posted: May 9, 2014