Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
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ClinicalTrials.gov Identifier: NCT00262288 |
Recruitment Status
:
Completed
First Posted
: December 6, 2005
Last Update Posted
: February 22, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Genetic Disorders | Drug: i.v. recombinant human C1 inhibitor | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II/III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | January 2007 |
Actual Study Completion Date : | January 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Recombinant Human C1INH |
Drug: i.v. recombinant human C1 inhibitor
Other Name: rhC1INH
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- Primary outcomes: Relief of angioedema symptoms [ Time Frame: 24 hours ]
- Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics [ Time Frame: 90 days ]

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Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main inclusion Criteria:
- Clinical and laboratory diagnosis of HAE
- Plasma level of functional C1INH of less than 50% of normal
- Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE.
Main exclusion Criteria:
- Acquired angioedema
- Pregnancy or breastfeeding
- Participation in another clinical study within prior 3 months

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): NCT00262288
Netherlands | |
For information on sites in Europe, please contact Pharming Technologies. | |
Leiden, Netherlands, 2333 CN |
Study Chair: | Jan Nuijens, MD, PhD | Pharming Technologies B.V. |
Responsible Party: | Pharming Technologies B.V. |
ClinicalTrials.gov Identifier: | NCT00262288 History of Changes |
Other Study ID Numbers: |
C1 1203-01 |
First Posted: | December 6, 2005 Key Record Dates |
Last Update Posted: | February 22, 2013 |
Last Verified: | February 2013 |
Additional relevant MeSH terms:
Angioedema Angioedemas, Hereditary Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |