DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Emphysema; Alpha 1-proteinase Inhibitor Deficiency

Intervention: Alpha1- proteinase inhibitor [human] (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Program Director, Clinical R&D, Study Director, Affiliation: CSL Behring

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).

Clinical Details

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

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

Primary outcome: Rate of change of lung density

Secondary outcome:

Number of pulmonary exacerbations

Lung function as measured by forced expiratory volume in 1 second (FEV1)

Change in adjusted lung density

Percent change in adjusted lung density

Quality of Life (QoL)

Lung function as measured by ratio of FEV1/FVC (forced vital capacity)

Annual rate of pulmonary exacerbations

Time to first onset of pulmonary exacerbation

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Study Site, Darlinghurst 2010, Australia

Study Site, Nedlands 6009, Australia

Study Site, New Lambton 2305, Australia

Study Site, Praha 4 - Krc 14059, Czech Republic

Study Site, Arhus C 8000, Denmark

Study Site, Hellerup 2900, Denmark

Study Site, Tartu 51014, Estonia

Study Site, Oulu 90220, Finland

Study Site, Essen 45209, Germany

Study Site, Heidelberg 69126, Germany

Study Site, Nürnberg 90419, Germany

Study Site, Dublin 9, Ireland

Study Site, Krakow 31-066, Poland

Study Site, Warsaw 01-138, Poland

Study Site, Bucuresti 011026, Romania

Study Site, Malmo 20502, Sweden

Study Site, Vancouver, British Columbia V5Z4E1, Canada

Study Site, Halifax, Nova Scotia B3H 3A7, Canada

Study Site, Toronto, Ontario M5T 2S8, Canada

Study Site, Adelaide, South Australia 5000, Australia

Study Site, Fitzroy, Victoria 3065, Australia

Additional Information

Click here to request more information about this study

Starting date: April 2008
Last updated: September 30, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017