Clinical Trial: Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 3, Open-label, Single-period Study to Evaluate the Safety and Treatment Effect of Intravenous Administration of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of B
Brief Summary: The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome:
- Safety and tolerability of CINRYZE administered by intravenous (IV) as measured by adverse events and changes in physical examinations, vital signs, and clinical safety laboratory testing [ Time Frame: Baseline to week 12 ]
- Pharmacokinetics (PK) of CINRYZE as measured by Concentrations of C1 INH antigen (protein volume) [ Time Frame: Baseline to week 12 ]
- Treatment effect of CINRYZE administered by IV infusion for the prevention [ Time Frame: Baseline to week 12 ]
- Treatment of breakthrough attacks as measured by the overall severity of the attack [ Time Frame: Baseline to week 12 ]
- Pharmacodynamics (PD) of CINRYZE as measured by Concentrations of C1 INH antigen (protein volume) [ Time Frame: Baseline to week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Shire
Dates:
Date Received: August 9, 2016
Date Started: September 2016
Date Completion: June 2017
Last Updated: March 29, 2017
Last Verified: March 2017
