Current clinical trials in Canada for individuals diagnosed with Alpha-1 Antitrypsin Deficiency include:
Efficacy and Safety of Alpha-1 Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha-1 Antitrypsin Deficiency
Principle Investigator: Dr. Kenneth R. Chapman, M.D., M.Sc., FRCPC, FACP, FCCP
If you have alpha-1 antitrypsin deficiency (type ZZ, SZ, Z (null), (null) (null), S (null), or “at-risk” alleles) and emphysema, you might be interested in a Clinical Trial of alpha-1 MP. This product has been approved in Canada for intravenous infusion at a dose of 60 mg/kg/week, to treat severe alpha-1 antitrypsin deficiency. This study is considered research because the infusions have not been approved in all countries, or at higher dose of 120 mg/kg/week.
Participants in the study will either receive 60 mg/kg/week of study drug, 120 mg/kg/week of study drug or a placebo (no active medication). This is a randomized placebo controlled trial; which means you are put into one of the 3 groups by chance and neither you nor the study doctor will know whether you are receiving active medication or placebo.
To be eligible, you must be 18 to 70 years old, and be a non-smoker or must have quit smoking for at least 12 months, and have airflow obstruction (FEV1 between 30% and 80% of predicted). The purpose of this study is to determine if weekly infusions over a period of 3 years will be effective to reduce the progression of emphysema.
The initial 3 infusions will be given under physician supervision in Toronto, and subsequent infusions will be given weekly at subjects’ homes by qualified nurses. The treatment is over a period of 3 years with visits every 3 months for the first year, then every 6 months for the second and third year in Toronto. Subjects will be reimbursed for their travel expenses for these visits. For subjects coming from out of town, airplane travel and hotel accommodations if required will be prepaid.
For more information, please contact Jane Duke, Clinical Trials Coordinator, Asthma & Airway Centre, Toronto Western Hospital.
Tel: 416-603-5800 Ext. 3438