Study Stopped
PennState would not allow the study to move forward
C1-INH Compared to Placebo at the Time of Prodromal Symptoms for Hereditary Angioedema (HAE) Exacerbation
Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Determine the Efficacy of 1000u, and 1500u of C1-INH Compared to Placebo at the Time of Prodromal Symptoms in Preventing an Acute HAE Exacerbation.
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The study hypothesis is that treatment of Hereditary Angioedema at the time of prodromal symptoms will decrease morbidity associated with the disease
Trial Health
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Started Jul 2010
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 28, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 30, 2012
November 1, 2012
2 years
June 25, 2010
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage of full blown HAE attacks occurring within 24 hours following treatment at the prodromal
To compare the percentage of full blown HAE attacks occurring within 24 hours following treatment at the prodromal stage of an attack using placebo or one of two doses of C1-INH.
24 hours
Study Arms (3)
C-1-esterase inhibitor 1000 units
ACTIVE COMPARATOR1000 units of C-1-esterase inhibitor given at time of prodromal symptoms
1500 units of C-1-esterase inhibitor
ACTIVE COMPARATORtreatment with 1500 units of C-1-esterase inhibitor IV at the time of prodromal symptoms to decrease risk of exacerbation of HAE
placebo injection
PLACEBO COMPARATORplacebo injection given for prodromal symptoms as double blinded therapy
Interventions
1000 units of C-1-esterase inhibitor
Eligibility Criteria
You may qualify if:
- Documented HAE type 1 or 2 by C4 level and C1-INH level or function.
- Able to read, understand, and sign informed consent.
- Above the age of 12 years.
- Willing to complete daily diary.
- Have at least 1 HAE exacerbations per month averaged over the last 6 months.
- Present for treatment within 6 hours of onset of prodromal symptoms.
- Treatment for an acute attack can be given at any time without restriction.
You may not qualify if:
- Inability to read English.
- Prior adverse effects to C1-INH.
- Participation in alternate investigational drug trial.
- Diabetes, neurologic diseases, cardiac diseases, dermatologic diseases that may have associated symptoms that mimic prodromal symptoms.
- Inability to withdraw from androgens or C1-INH prophylaxis.
- Pregnant or breast feeding mothers.
- Prisoners or other institutionalized individuals.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Lunn, DO
Penn State University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 25, 2010
First Posted
June 28, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 30, 2012
Record last verified: 2012-11