Prophylactic Use of C1INH-nf (C1 Esterase Inhibitor)to Prevent HAE(Hereditary Angioedema)Attacks - Full Text View

Sponsor:	ViroPharma
Information provided by:	ViroPharma
ClinicalTrials.gov Identifier:	NCT00462709

Purpose

This open-label study will evaluate the efficacy and safety of C1 Esterase Inhibitor (C1INH-nf)as prophylactic treatment to prevent Hereditary Angioedema(HAE) attacks and in treatment of acute HAE attacks.

Condition	Intervention	Phase
Hereditary Angioedema	Drug: C1 esterase inhibitor [human] (C1INH-nf)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Protocol LEVP2006-4: CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open Label Use of C1 Esterase Inhibitor (Human) for the Prophylactic Treatment to Prevent Hereditary Angioedema(HAE) Attacks and as Treatment in Acute HAE Attacks.

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary angioedema Help Me Understand Genetics

Drug Information available for: C1 esterase inhibitor

U.S. FDA Resources

Further study details as provided by ViroPharma:

Primary Outcome Measures:

The presence or absence of unequivocal beginning of relief of the defining symptom within 4 hours.

Secondary Outcome Measures:

Change in time to the unequivocal beginning of relief of the defining symptom for subjects who receive multiple treatments.
The ability of C1INH-nf concentrate to raise C1INH and C4 levels.
Safety will be assessed by the number and severity of adverse experiences, and changes in clinical laboratory safety parameters.

Estimated Enrollment:	150
Study Start Date:	June 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have a history of at least 1 HAE attack per month or a history of laryngeal attacks
Subjects enrolled in LEVP2005-1 Part B or eligible for Part B after LEVP2005-1 closes
Subjects excluded from LEVP2005-1 due to:
- Pregnancy or lactation
- Age less than 6 years
- Narcotic addiction
- Presence of C1INH autoantibody May be enrolled in 2006-4.
Subjects not enrolled in LEVP2005-1 may enroll in 2006-4:
- Diagnosis of HAE based on a low C1INH Antigen and/or Functional and a Low C4.
- Documented of HAE causing C1INH Mutation
- Diagnosis of HAE based on a strong family history of HAE as determined by the Principal Investigator

Exclusion Criteria:

History of allergic reaction to C1INH or other blood products
Current participation in any other investigational drug study within the past 30 days
Received blood or a blood product in the past 60 days other than C1INH-nf

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462709

Show 46 Study Locations

Sponsors and Collaborators

ViroPharma

Investigators

Principal Investigator:

Bruce Zuraw, MD

UCSD

More Information

No publications provided

Responsible Party:	ViroPharma
Study ID Numbers:	LEVP2006-4
Study First Received:	April 17, 2007
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00462709 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ViroPharma:

hereditary angioedema, C1 esterase inhibitor

Additional relevant MeSH terms:

Skin Diseases, Vascular
Immunologic Factors
Angioedema
Skin Diseases
Immune System Diseases
Physiological Effects of Drugs
Vascular Diseases
Angioedema, Hereditary
Urticaria

Immunosuppressive Agents
Pharmacologic Actions
Complement C1s
Hypersensitivity
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Cardiovascular Diseases
Complement Inactivating Agents
Complement C1 Inhibitor Protein

ClinicalTrials.gov processed this record on February 08, 2010