A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration (OPERA)
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|ClinicalTrials.gov Identifier: NCT00851409|
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : January 31, 2013
Last Update Posted : June 26, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Genetic Disorders Hereditary Angioedema||Drug: Recombinant Human C1 Inhibitor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE")|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
Recombinant Human C1 Inhibitor
Weekly administration of 50 IU/kg Recombinant Human C1 Inhibitor
Drug: Recombinant Human C1 Inhibitor
50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period.
- HAE Attacks/Week [ Time Frame: 8 weeks ]Prior to the treatment period, patients enrolled in the study, were asked about the amount of "HAE" attacks in the past 2 years, (calculated to attacks/week), this number is defined as "Historical". During the treatment period, patients received a dose of 50 IU/kg of "rhC1INH" administered by slow "IV" injection over 4 to 5 minutes, once a week during an eight week period. The amount of attacks during this period is defined as "Prophylaxis" (calculated to attacks/week).
- The Evaluation of Pharmacokinetic/ Pharmacodynamic ("PK/PD")Parameters. [ Time Frame: 8 weeks ]"PK/PD" parameters will be based on concentration time curves after the 1st and 8th "rhC1INH" administration.(ratio visit 8/ visit 1, based on the area under the curve from baseline up to 4 hours after administration (AUC 0-4)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Aged at least 18 years
- Signed informed consent
- Comfirmed diagnosis of HAE with baseline plasma level of functional C1INH activity of less than 50% of normal, and/or proven HAE ,mutation in C1INH gene.
- A history of anaphylaxis or severe allergy (i.e. requiring medication) to food, proteins and/or drugs.
- A history of allergic reactions to C1INH products or rabbit protein.
- Any reported SAE related to study drug administration (withdrawal criterium)
- Elevated IgE against rabbit dander (>0.35 kU/L; ImmunoCap assay; Phadia)
- A diagnosis of acquired C1INH deficiency.
- Woman of child bearing potential, pregnancy or breast-feeding
- previous treatment within the last 3 months with plasma-derived C1INH
- Any clinically significant abnormality in the routine haematology, biochemistry and urinalysis
- Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives.
- Any changes since screening that would exclude subject based on above exclusion criteria.
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): NCT00851409
|For information on sites, please contact Pharming Technologies|
|Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department|
|Târgu-Mureş, Romania, 541103|
|Study Chair:||Bruno Giannetti, MD||COO Pharming|
|Responsible Party:||Pharming Technologies B.V.|
|Other Study ID Numbers:||
|First Posted:||February 26, 2009 Key Record Dates|
|Results First Posted:||January 31, 2013|
|Last Update Posted:||June 26, 2018|
|Last Verified:||April 2018|
Genetic Diseases, Inborn
Skin Diseases, Vascular
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Complement C1 Inhibitor Protein
Complement Inactivating Agents
Physiological Effects of Drugs