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Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

P

Pharming Healthcare

Status and phase

Completed
Phase 3
Phase 2

Conditions

Genetic Disorders

Treatments

Drug: i.v. recombinant human C1 inhibitor

Study type

Interventional

Funder types

Industry

Identifiers

NCT00262288
C1 1203-01

Details and patient eligibility

About

The purpose of this multi-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Enrollment

14 patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Recombinant Human C1INH
Experimental group
Treatment:
Drug: i.v. recombinant human C1 inhibitor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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