EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
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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: NCT01826916 |
Recruitment Status :
Completed
First Posted : April 9, 2013
Last Update Posted : May 18, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hereditary Angioedema (HAE) | Drug: DX-88 (ecallantide) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 77 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of DX-88 (Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema |
Actual Study Start Date : | November 1, 2003 |
Actual Primary Completion Date : | December 1, 2005 |
Actual Study Completion Date : | January 1, 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 5mg/m2 DX-88 IV
5mg/m2 DX-88 (ecallantide)administered intravenously
|
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL |
Experimental: 10mg/m2 DX-88 IV
10mg/m2 DX-88(ecallantide)administered intravenously
|
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL |
Experimental: 20mg/m2 DX-88 IV
20mg/m2 DX-88 (ecallantide) administered intravenously
|
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL |
Experimental: 30 mg DX-88 SC
30mg DX-88(ecallantide)administered subcutaneously
|
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL |
- Proportion of attacks treated with successful outcome [ Time Frame: 24 hours ]successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours
- Proportion of attacks with a partial response [ Time Frame: 24 hours ]partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours
- Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response [ Time Frame: 24 hours ]
- Time to resolution onset of each acute attack, as determined by patient report [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826916
Study Director: | Study Director | Takeda |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01826916 |
Other Study ID Numbers: |
DX-88/5 EDEMA2 ( Other Identifier: Dyax ) |
First Posted: | April 9, 2013 Key Record Dates |
Last Update Posted: | May 18, 2021 |
Last Verified: | May 2021 |
Angioedema Angioedemas, Hereditary Ecallantide Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Hereditary Complement Deficiency Diseases |
Primary Immunodeficiency Diseases Genetic Diseases, Inborn Immunologic Deficiency Syndromes Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |