C1-INH Compared to Placebo at the Time of Prodromal Symptoms for Hereditary Angioedema (HAE) Exacerbation

• Status: Withdrawn
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that treatment of Hereditary Angioedema at the time of prodromal symptoms will decrease morbidity associated with the disease

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penn State University
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

Inclusion Criteria:

1. Documented HAE type 1 or 2 by C4 level and C1-INH level or function.

2. Able to read, understand, and sign informed consent.

3. Above the age of 12 years.

4. Willing to complete daily diary.

5. Have at least 1 HAE exacerbations per month averaged over the last 6 months.

6. Prodromal symptoms will not be an inclusion or exclusion since if used it would bias our ability to determine specificity and sensitivity of prodromal symptoms.

7. Present for treatment within 6 hours of onset of prodromal symptoms.

8. Treatment for an acute attack can be given at any time without restriction.

Exclusion Criteria:

1. Inability to read English.

2. Prior adverse effects to C1-INH.

3. Participation in alternate investigational drug trial.

4. Diabetes, neurologic diseases, cardiac diseases, dermatologic diseases that may have associated symptoms that mimic prodromal symptoms.

5. Inability to withdraw from androgens or C1-INH prophylaxis.

6. Pregnant or breast feeding mothers.

7. Prisoners or other institutionalized individuals.