Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
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|ClinicalTrials.gov Identifier: NCT00262301|
Recruitment Status : Completed
First Posted : December 6, 2005
Results First Posted : August 30, 2012
Last Update Posted : October 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Angioedema Angioneurotic Edema Genetic Disorders||Drug: recombinant human C1 inhibitor Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo-controlled, Double-blind Phase 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 :||June 2004|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||October 2009|
Experimental: 100 IU/kg "rhC1INH"
100 IU/kg recombinant human C1 inhibitor
Drug: recombinant human C1 inhibitor
Placebo Comparator: Saline
- Time to Beginning of Relief of Symptoms [ Time Frame: up to 48 hours after study drug administration ]The time to beginning of relief of symptoms has been assessed by using a patient-reported visual analogue scale ("VAS") ranging from 0 mm (no symptoms at all) to 100 mm (extremely disabling). Time to beginning of relief of symptoms at the location that showed first "VAS" score decrease of at least 20 mm from baseline score (t= 0 min) to the next assessment time-point). Assessment time-points were taken on pre-scheduled time-points after drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to beginning of relief has been calculated as median time, by using the exact time-points on which each assessment was performed.
- Time to Minimal Symptoms [ Time Frame: up to 48 hours after study drug administration ]the time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale ("VAS") score. Symptoms were said to be minimal when the "VAS" score at all locations was below 20 mm. Assessment time-points were: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to minimal symptoms has been calculated by using the exact time-points on which each assessment was performed.
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): NCT00262301
|For information on sites, please contact Pharming Medical Affairs Deparment|
|Leiden, Netherlands, 2300 AL|
|Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department|
|Tirgu Mures, Romania, 541103|
|Study Chair:||Jan Nuijens, MD, PhD||Pharming Group N.V.|