Trial record 16 of 48 for:    "alpha-1 antitrypsin deficiency"

Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00670007
First received: April 29, 2008
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

This study is a continuation of the placebo-controlled study CE1226_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® i.v. administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).


Condition Intervention Phase
Emphysema
Alpha 1-proteinase Inhibitor Deficiency
Biological: Alpha1- proteinase inhibitor [human]
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non-controlled, Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Zemaira® Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency Who Completed Clinical Study CE1226_4001

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Rate of change of lung density [ Time Frame: Yearly, for up to 2 years ] [ Designated as safety issue: No ]
    The annualized rate of change of lung density measured by volume-adjusted CT.


Secondary Outcome Measures:
  • Number of pulmonary exacerbations [ Time Frame: For the duration of the study, up to 2 years ] [ Designated as safety issue: No ]
  • Lung function as measured by forced expiratory volume in 1 second (FEV1) [ Time Frame: Once every 3 months for the duration of the study, up to 2 years. ] [ Designated as safety issue: No ]
  • Change in adjusted lung density [ Time Frame: Baseline, and completion visit (up to 2 years) ] [ Designated as safety issue: No ]
    Absolute change from baseline to the completion visit. The baseline value will be the last assessment from the preceding study CE1226_4001.

  • Percent change in adjusted lung density [ Time Frame: Baseline, and completion visit (up to 2 years) ] [ Designated as safety issue: No ]
    Percent change in adjusted lung density from baseline to the completion visit. The baseline value will be the last assessment from the preceding study CE1226_4001.

  • Quality of Life (QoL) [ Time Frame: At 12 and 24 months ] [ Designated as safety issue: No ]
    QoL will be assessed using the disease-specific St. George's Respiratory Questionnaire (SGRQ)

  • Lung function as measured by ratio of FEV1/FVC (forced vital capacity) [ Time Frame: Once every 3 months for the duration of the study, up to 2 years. ] [ Designated as safety issue: No ]
  • Annual rate of pulmonary exacerbations [ Time Frame: For the duration of the study, up to 2 years ] [ Designated as safety issue: No ]
  • Time to first onset of pulmonary exacerbation [ Time Frame: For the duration of the study, up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: April 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zemaira Biological: Alpha1- proteinase inhibitor [human]
Lyophilized preparation of 60 mg/kg body weight intravenously once per week
Other Name: Zemaira®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed the 2-year treatment and observation period in the Phase 3/4 Zemaira® CE1226_4001 study (NCT00261833) and are willing to sign informed consent
  • Males, and non-pregnant, non-lactating females, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator

Exclusion Criteria:

  • Individuals residing in the US
  • Current evidence of alcohol abuse or abuse of drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids
  • History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol
  • Current tobacco smoker (smoking must be discontinued for at least 6 months prior to study participation)
  • Conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator
  • History of non-compliance
  • Administration of any other experimental new drug or participation in an investigation of a marketed product
  • Inability to perform necessary study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670007

  Show 22 Study Locations
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Program Director, Clinical R&D CSL Behring
  More Information

Additional Information:
No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00670007     History of Changes
Other Study ID Numbers: CE1226_3001, 1466, 2007-007129-38
Study First Received: April 29, 2008
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee
Ireland: Irish Medicines Board
Ireland: Medical Ethics Research Committee
Finland: Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Finland: Finnish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Paul-Ehrlich-Institut
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Romania: National Medicines Agency
Sweden: Medical Products Agency

Keywords provided by CSL Behring:
Alpha1-proteinase inhibitor deficiency
Chronic augmentation and maintenance therapy
Emphysema
Emphysema due to Alpha 1-proteinase inhibitor deficiency

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Emphysema
Pulmonary Emphysema
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Pathologic Processes
Alpha 1-Antitrypsin
Protease Inhibitors
Trypsin Inhibitors
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014