Clinical trials are research studies performed on human subjects. Studies conducted on animals, in test tubes, or using various other laboratory techniques are often called basic research. Clinical trials may include studies to evaluate the course of a disease, its cause or a treatment. Testing of new drugs or therapies is often the most visible and exciting type of clinical trial. In Canada, clinical trials that evaluate a new drug or pharmaceutical therapy fall under very strict regulation by Health Canada. Health Canada decides whether the studies performed show that a drug is effective enough and safe enough to warrant broad distribution of the drug to patients. You can register with the Alpha-1 Canadian Registry to find out about clinical trials and research projects you may be eligible to participate in. Participating in research is a tangible way for you to take part in the quest to improve the lives of all Alphas – including yourself – and be a part of eventually finding a cure for this devastating disease. Dr. Kenneth R. Chapman, M.D., M.Sc., FRCPC, FACP, FCCP
Information for subjects with Alpha1-antitrypsin deficiency & emphysema
If you have 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 Antitrypsin Deficiency). This study is considered research because the infusions have not been approved in all countries or at the 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 EW7 Room 445, Toronto Western Hospital -Toronto, Ontario M5T 2S8 – 416 603 5800 ext 3438 – Fax: 416 603 5020 firstname.lastname@example.org
If you have Alpha-1 Liver Disease you could help find out whether carbamazepine can reduce the severity of Liver Disease that occurs in people with Alpha-1 Antitrypsin Deficiency. Click here for more details.
Research registries are lists of patients who have agreed to consider requests to take part in research on Alpha-1. Joining a registry does not mean that you agree to take part in research, only that you agree to receive requests from researchers who are studying Alpha-1.
Alpha-1 Canadian Registry
The Alpha-1 Canadian Registry was established in 1999 to gather information on Alpha-1 in order to study the natural history of the disorder and to conduct studies and clinical trials. All information in the registry is strictly confidential. The registry is open to both patients and carriers. Consent to become part of the registry does not mean consent for clinical studies. Individuals are free to withdraw their names from the registry at any time, should they so choose. Contact the registry at: www.alpha1canadianregistry.com email@example.com Alpha-1 Canadian Registry Toronto Hospital, Western Division, Edith Cavell Wing, # 4-011, 399 Bathurst Street, Toronto, Ontario, MT5 2S8 The toll free number is: 1-800-352-8186
Alpha-1 International Registry (AIR)
Canada is a member of the Alpha-1 International Registry (AIR) which is composed of about twenty countries who have national alpha-1 registries. The aim of AIR is to exchange information about alpha-1 among medical professionals and to coordinate and combine research into alpha-1. The organization has established an international database in Mälmo, Sweden, the city where alpha-1 was first discovered. For more information on AIR and participating countries, visit the website at www.aatregistry.org
Alpha-1 Foundation Research Registry (USA)
The Alpha-1 Foundation Research Registry is located at the Medical University of South Carolina (MUSC) and is open to Canadians who wish to register. Its purpose is to facilitate research into alpha-1 and, like the Canadian registry, all information on participants is completely secure and confidential. It is also open to both patients and carriers. For more information, visit the website at www.alphaoneregistry.org Phone 1-877-886-2383.