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

Emphysema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670007
• Other study ID #: CE1226_3001
• Secondary ID: 14662007-007129-
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: September 2, 2015
• Start date: April 2008
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaCanada: Ethics Review CommitteeIreland: Irish Medicines BoardIreland: Medical Ethics Research CommitteeFinland: Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationFinland: Finnish Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Paul-Ehrlich-InstitutCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyEstonia: The State Agency of MedicineRomania: National Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Alpha 1-proteinase Inhibitor Deficiency
• Emphysema
• Pulmonary Emphysema

Intervention

Biological:
• Alpha1- proteinase inhibitor [human]
Lyophilized preparation of 60 mg/kg body weight intravenously once per week

Locations

Country	Name	City	State
Australia	Study Site	Adelaide	South Australia
Australia	Study Site	Darlinghurst
Australia	Study Site	Fitzroy	Victoria
Australia	Study Site	Nedlands
Australia	Study Site	New Lambton
Canada	Study Site	Halifax	Nova Scotia
Canada	Study Site	Toronto	Ontario
Canada	Study Site	Vancouver	British Columbia
Czech Republic	Study Site	Praha 4 - Krc
Denmark	Study Site	Arhus C
Denmark	Study Site	Hellerup
Estonia	Study Site	Tartu
Finland	Study Site	Oulu
Germany	Study Site	Essen
Germany	Study Site	Heidelberg
Germany	Study Site	Nürnberg
Ireland	Study Site	Dublin
Poland	Study Site	Krakow
Poland	Study Site	Warsaw
Romania	Study Site	Bucuresti
Sweden	Study Site	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

Australia,  Canada,  Czech Republic,  Denmark,  Estonia,  Finland,  Germany,  Ireland,  Poland,  Romania,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change of lung density	The annualized rate of change of lung density measured by volume-adjusted CT.	Yearly, for up to 2 years	No
Secondary	Number of pulmonary exacerbations		For the duration of the study, up to 2 years	No
Secondary	Lung function as measured by forced expiratory volume in 1 second (FEV1)		Once every 3 months for the duration of the study, up to 2 years.	No
Secondary	Change in adjusted lung density	Absolute change from baseline to the completion visit. The baseline value will be the last assessment from the preceding study CE1226_4001.	Baseline, and completion visit (up to 2 years)	No
Secondary	Percent change in adjusted lung density	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.	Baseline, and completion visit (up to 2 years)	No
Secondary	Quality of Life (QoL)	QoL will be assessed using the disease-specific St. George's Respiratory Questionnaire (SGRQ)	At 12 and 24 months	No
Secondary	Lung function as measured by ratio of FEV1/FVC (forced vital capacity)		Once every 3 months for the duration of the study, up to 2 years.	No
Secondary	Annual rate of pulmonary exacerbations		For the duration of the study, up to 2 years	No
Secondary	Time to first onset of pulmonary exacerbation		For the duration of the study, up to 2 years	No

External Links

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