Status:
COMPLETED
EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
Lead Sponsor:
Shire
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioed...
Eligibility Criteria
Inclusion
- 10 years of age or older
- Documented diagnosis of HAE (Type I or II)
- Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack
- Willing and able to give informed consent
Exclusion
- Patients with a serious intercurrent illness or serious active infection
- Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal
- Receipt of an investigational drug or device, within 30 days prior to study treatment
- Pregnancy or breastfeeding
- Diagnosis of acquired angioedema (AAE)
- Patients who had not completed their Day-7 follow-up procedures for a previously treated attack
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01826916
Start Date
November 1 2003
End Date
January 1 2006
Last Update
May 18 2021
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