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Kinetics, Efficacy and Safety of C1-Esteraseremmer-N

This study has been completed.
Sponsor:
Information provided by:
Sanquin
ClinicalTrials.gov Identifier:
NCT00119431
First received: July 4, 2005
Last updated: May 1, 2009
Last verified: May 2009

July 4, 2005
May 1, 2009
September 2005
Not Provided
Pharmacokinetics of C1-esteraseremmer-N versus Cetor.
Same as current
Complete list of historical versions of study NCT00119431 on ClinicalTrials.gov Archive Site
Laboratory and clinical safety as well as clinical tolerance of C1-esteraseremmer-N versus current Cetor.
Same as current
Not Provided
Not Provided
 
Kinetics, Efficacy and Safety of C1-Esteraseremmer-N
Pharmacokinetics, Clinical Efficacy and Safety of C1 Inhibitor Concentrate (C1-Esteraseremmer-N) for the Treatment of Hereditary (and Acquired) Angioedema

A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be performed. This study KB2003.01 consists of three parts, part A pharmacokinetics (phase II), part B treatment of attacks of angioedema (phase III) and part C prophylactic use of C1 inhibitor (phase III). Part B + C will provide data on the efficacy of C1-esteraseremmer-N.

The changes in the manufacturing process of C1-esteraseremmer-N, compared to Cetor® (the currently marketed C1-inhibitor product), nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide more safety regarding viruses.

In part A, the pharmacokinetics of C1-esteraseremmer-N in patients with hereditary angioedema will be compared with the current registered product, Cetor®, in a randomised, blinded cross-over design. This study has to provide evidence that changes in the manufacturing process have not affected pharmacokinetics. In addition, this study provides data on safety of C1-esteraseremmer-N.

A multicentre study to investigate pharmacokinetics, clinical efficacy and safety of nanofiltered Cetor® (called C1-esteraseremmer-N during the development phase) for the treatment of hereditary angioedema (HAE) will be performed. This study KB2003.01 consists of three parts, part A pharmacokinetics (phase II), part B treatment of attacks of angioedema (phase III) and part C prophylactic use of C1 inhibitor (phase III). Part B + C will provide data on the efficacy of C1-esteraseremmer-N.

The changes in the manufacturing process of C1-esteraseremmer-N, compared to Cetor® (the currently marketed C1-inhibitor product), nanofiltration and omission of hepatitis B immunoglobulin, most likely will not affect tolerability. The nanofiltration will provide more safety regarding viruses.

In part A, the pharmacokinetics of C1-esteraseremmer-N in patients with hereditary angioedema will be compared with the current registered product, Cetor®, in a randomised, blinded cross-over design. This study has to provide evidence that changes in the manufacturing process have not affected pharmacokinetics. In addition, this study provides data on safety of C1-esteraseremmer-N. Twelve HAE patients without signs of an attack will receive an administration of 1,000 U, 1,500 U or 2,000 U of C1-esteraseremmer-N or Cetor® and later on the same dose of the other product. Both antigenic and functional C1 inhibitor levels will be determined. Laboratory safety parameters and adverse events will be monitored as well

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Hereditary Angioedema Type I
  • Angioneurotic Edema
Drug: C1 inhibitor concentrate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2006
Not Provided

Inclusion Criteria:

  • Established diagnosis of hereditary angioedema type I: i.e. markedly decreased C1 inhibitor activity, decreased level of C1 inhibitor antigen and a decreased level of C4.
  • Age ≥ 18 years
  • Body weight between 40 and 100 kg.
  • Signed Informed consent

Exclusion Criteria:

  • C1 inhibitor infusion within the last 7 days
  • Signs of any attack
  • Angioedema attack within 7 days before actual infusion of study medication
  • Change in the dosage of androgens in the last 14 days before the study
  • Change in oral anticonceptive medication in the last two months before the study
  • Pregnancy or lactation.
  • B-cell malignancy
  • Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study
  • History of clinically relevant antibody development to C1 inhibitor
  • Use of oral anticoagulant medication in the last 14 days
  • Use of heparin within the last two days prior to the study
  • History of allergic reaction to C1 inhibitor concentrate or other blood products
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00119431
KB2003.01A
Not Provided
Not Provided
Sanquin
Not Provided
Principal Investigator: M. M. Levi, Prof. Dr. Academic Medical Centre Amsterdam
Sanquin
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP