Patisiran is an investigational drug that uses the body's natural processes to lower the levels of TTR protein that cause TTR amyloidosis (FAP). It does so by targeting and silencing specific messenger RNA, blocking the production of TTR protein before it is made. This may help significantly reduce the level of TTR protein in the body, which may slow or halt the progression of TTR amyloidosis (FAP).
Clinical trials like APOLLO are conducted by trained study staff committed to supporting trial participants. APOLLO participants will receive regular study-related support—including study-related medical care every 3 weeks and comprehensive monitoring.
All participants will be monitored at every visit. Study staff will periodically evaluate the progression of each patient’s TTR amyloidosis (FAP).
What to expect
All APOLLO participants will be randomly assigned to receive either patisiran or placebo. 2 out of 3 (67%) participants will receive patisiran. For up to 18 months, participants will receive their assigned study drug (patisiran or placebo) once every 3 weeks, along with study-related monitoring and care.
At 9 and 18 months, participants will also have extensive, all-day exams* to see how the study drug may be affecting their TTR amyloidosis (FAP). Participants whose condition has progressed significantly by 9 months will work with their study doctor to determine next steps.
Participants who complete their 18-month assessment may be eligible to receive patisiran as part of an extended clinical trial. This study is expected to commence in 2015. Participants must meet certain eligibility criteria in order to take part.*Participants may need to travel to some or all of these visits. We understand that this may require some effort for participants and caregivers, and we’ll do our best to make travel as convenient and comfortable as possible. Contact Alnylam to learn more about the travel-related services APOLLO clinical trial sites can offer.
Could you be eligible?
Why clinical trials
Patients with TTR amyloidosis (FAP) have limited treatment options. Participants in a clinical trial may potentially have access to an investigational drug that may impact their disease.
Why take part? Participants will contribute to a greater understanding of the disease. Those who enroll will also play a critical part in the efforts to advance the treatment of TTR amyloidosis (FAP)—both for today’s patients and for those who may inherit this condition in the future.