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A Study to Evaluate Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy
EU CTIS ID: 2024-518343-38-00
What this study is testing
To obtain safety data on the use of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy who o continued on extended use of vutrisiran, or o switched from patisiran
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients with ATTR amyloidosis (hereditary or wt) who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003.
- 2. Willingness to adhere to vitamin A supplementation per protocol.
- 3. Patient or legal guardian, where relevant and allowable by law, is able to understand and is willing and able to comply with the study requirements and to provide written informed consent.
You likely can't join if
- 1. Permanently discontinued study drug administration while participating in the parent studies, Study ALN-TTR02-011, Study ALN-TTR02-014, or Study ALN-TTRSC02-003.
- 2. Future or current participation in another investigational device or drug study, scheduled to occur during this study.
- 3. Requires treatment with or is unwilling to avoid any concurrent treatment with non-dihydropyridine calcium channel blockers (eg, verapamil, diltiazem).
- 4. Has other medical conditions or comorbidities (eg, malignancy, neuropsychiatric disorder) which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
- 5. Is not willing to comply with the contraceptive requirements during the study period.
- 6. Female patient is pregnant, planning a pregnancy, or breast-feeding.
See the full eligibility criteria
- 1. Patients with ATTR amyloidosis (hereditary or wt) who are participating in the patisiran parent studies ALN-TTR02-011 or ALN-TTR02-014 or who have completed the 24-month OLE Period in the vutrisiran parent study ALN-TTRSC02-003.
- 2. Willingness to adhere to vitamin A supplementation per protocol.
- 3. Patient or legal guardian, where relevant and allowable by law, is able to understand and is willing and able to comply with the study requirements and to provide written informed consent.
- 1. Permanently discontinued study drug administration while participating in the parent studies, Study ALN-TTR02-011, Study ALN-TTR02-014, or Study ALN-TTRSC02-003.
- 2. Future or current participation in another investigational device or drug study, scheduled to occur during this study.
- 3. Requires treatment with or is unwilling to avoid any concurrent treatment with non-dihydropyridine calcium channel blockers (eg, verapamil, diltiazem).
- 4. Has other medical conditions or comorbidities (eg, malignancy, neuropsychiatric disorder) which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
- 5. Is not willing to comply with the contraceptive requirements during the study period.
- 6. Female patient is pregnant, planning a pregnancy, or breast-feeding.
- 7. Unwilling or unable to limit alcohol consumption throughout the course of the study. Alcohol intake of >2 units/day is excluded during the study (unit: 1 glass of wine [approximately 125 mL] = 1 measure of spirits [approximately 1 fluid ounce] = ½ pint of beer [approximately 284 mL]).
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Taiwan
- United Kingdom
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Taiwan; United Kingdom; United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.