Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01188564
• Date of registration: 24/08/2010
• Prospective Registration: Yes
• Primary sponsor: Pharming Technologies B.V.
• Public title: Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
• Scientific title: A Phase III Randomized, Double-blind, Placebo-controlled Study With an Open-label Extension Evaluating the Efficacy, Safety and Immunogenicity of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks of Angioedema in Patients With HAE
• Date of first enrolment: January 2011
• Target sample size: 75
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01188564
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Hungary, Israel, Italy, Macedonia, The Former Yugoslav Republic of, Netherlands, Poland, Romania, Serbia, South Africa, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged at least 13 years

- Signed written informed consent

- Clear clinical and laboratory diagnosis of HAE with baseline plasma level of
functional C1INH of less than 50% of normal

- Willingness and ability to comply with all protocol procedures

- Clinical symptoms of an eligible HAE attack with onset less than 5 hours before the
time of initial evaluation

Exclusion Criteria:

- Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH),
or positive anti-rabbit dander IgE test (cut off >0.35 kU/L; ImmunoCap® assay; Phadia
or equivalent).

- A diagnosis of acquired C1INH deficiency (AAE)

- Pregnancy, or breastfeeding, or current intention to become pregnant

- Treatment with any investigational drug in the past 30 days

- Known or suspected addiction to drug and/or alcohol abuse

- Suspicion for an alternate explanation of the symptoms other than acute HAE attack



Age minimum: 13 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hereditary Angioedema

Intervention(s)

Drug: Placebo (Saline)

Drug: rhC1INH

Primary Outcome(s)

Time to Beginning of Relief of Symptoms [Time Frame: Patients observed for 24 hours]

Secondary Outcome(s)

Time to Minimal Symptoms [Time Frame: 24 hours]

Secondary ID(s)

C1 1310

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01188564