Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor (API) Deficiency
Tracking InformationStart Date ICMJE | March 2006 |
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Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: January 3, 2008) | Lung density as measured by CT [ Time Frame: 5 times during study ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE (submitted: December 2, 2005) | Lung density as measured by CT |
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Change History | Complete list of historical versions of study NCT00261833 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: June 11, 2009) | - Number, severity, and duration of pulmonary exacerbations [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
- Lung function as measured by forced expiratory volume in 1 second (FEV1) and lung diffusing capacity for carbon monoxide (DLco) [ Time Frame: Once every 3 months during the study ] [ Designated as safety issue: No ]
- Antigenic and functional serum A1 - PI Levels [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]
- Body mass index [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]
- Exercise capacity [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Yearly ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE (submitted: December 2, 2005) | - Number, severity and duration of exacerbations
- Lung function as measured by FEV1 and DLco
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Descriptive InformationBrief Title ICMJE | Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor (API) Deficiency |
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Official Title ICMJE | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Phase III/IV Study to Compare the Efficacy and Safety of 60mg/kg Body Weight of Zemaira® Weekly I.V. Administration With Placebo Weekly I.V. Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency |
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Brief Summary | This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (CT). |
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Detailed Description | |
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Study Phase | Phase IV |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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Condition ICMJE | - Alpha1-proteinase Inhibitor Deficiency
- Emphysema
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Intervention ICMJE | |
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Study Arms / Comparison Groups | |
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Recruitment InformationEstimated Enrollment ICMJE | 180 |
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Estimated Completion Date | August 2012 |
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Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - 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.
- Diagnosis of alpha1-proteinase inhibitor deficiency (serum A1-PI levels < 11 μM or < 80 mg/dL). This includes newly diagnosed subjects, previously untreated subjects, currently treated subjects, and subjects currently not on treatment therapy but on treatment in the past.
- Subjects with emphysema and FEV1 ≥ 35 and ≤ 70% (predicted).
- No signs of chronic or acute Hepatitis A, Hepatitis B, Hepatitis C or HIV infection (negative serologies for HIV and viral hepatitis). In case of positive serologies for viral hepatitis, vaccination status or negative IgM should be available.
Exclusion Criteria: - Any relevant chronic diseases or history of relevant diseases (e.g., severe renal insufficiency) except respiratory or liver disease secondary to alpha1-proteinase inhibitor deficiency. Subjects with well-controlled, chronic diseases may be included after consultation with the treating physician and the sponsor.
- Current evidence of alcohol abuse or history of abuse of illegal and/or legally prescribed 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.
- History of transfusion reactions.
- Selective IgA deficiency.
- Acute illness within one week prior to the first administration of the investigational medicinal product (IMP). Start of treatment after recovery is possible.
- Current tobacco smoker (smoking has to be ceased at least 6 months prior study inclusion). Subjects with a positive cotinine test due to nicotine replacement therapy (e.g. patches, chewing gum) or snuff are eligible.
- Conditions or behaviors that interfere with attending scheduled study visits in opinion of the investigator.
- History of non-compliance.
- Administration of any other experimental new drug or participation in an investigation of a marketed product within one month prior to the screening visit date.
- Inability to perform necessary study procedures.
- Lung transplantation, lung volume reduction surgery or lobectomy or being on a waiting list for any such surgeries.
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Gender | Both |
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Ages | 18 Years to 65 Years |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | United States, Australia, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, Germany, Ireland, Poland, Romania, Russian Federation, Sweden |
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Administrative InformationNCT ID ICMJE | NCT00261833 |
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Responsible Party | Global Head Clinical Research & Development, CSL Behring |
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Study ID Numbers ICMJE | CE1226_4001, 1449 |
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Study Sponsor ICMJE | CSL Behring |
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Collaborators ICMJE | |
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Investigators ICMJE | Study Director: | Program Director, Clinical R&D | CSL Behring | |
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Information Provided By | CSL Behring |
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