Purpose of the CAD Studies.
The CAD Studies are being conducted by Bioverativ to determine the safety and effectiveness of the investigational medication BIVV009 in adults ages 18 and older who have primary cold agglutinin disease.
Who may qualify.
The CAD Studies may be appropriate for those who meet the following criteria:
- Males and females 18 years of age or older
- Those who have a confirmed diagnosis of primary cold agglutinin disease
- Both those who have had a blood transfusion in the last six (6) months and those who have not
Participation in either of these studies includes a six-week (6-week) screening/observation period where you will have to attend three (3) visits to determine if you qualify for one of the studies. If you meet the criteria, you will enroll into the study for which you qualify and enter a six-month (6-month) treatment period, where you will either (by chance, like the flip of a coin) receive the investigational medication or placebo.
After six (6) months, you will enter an open-label long-term extension phase so the study physician can continue to monitor the safety and effects of the investigational medication over time. During this phase, you will receive the investigational medication. This phase could last up to 24 months.
Lastly, a safety follow-up visit will take place six (6) weeks after the day you receive your last dose of the investigational medication, or earlier if you discontinue participation in the study. The total study duration is approximately 1.5 to 2.5 years.
Find a participating research site