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A research study to look at long-term treatment with a medicine called NNC6019-0001 for people who have heart failure due to transthyretin amyloidosis
EU CTIS ID: 2022-502605-15-00
What this study is testing
To assess the long-term safety and tolerability of NNC6019-0001 from baseline up to week 156 in participants with ATTRv-CM or ATTRwt-CM
- Therapeutic exploratory (Phase II)
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
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Completed study intervention in NN6019-4940 (a) and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. (a)- A participant who has not permanently discontinued study intervention as defined in NN6019-4940
- Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.
You likely can't join if
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 2.5 × the upper limit of normal (ULN) or total bilirubin ≥ 2 × ULN at screening.
- Body weight > 120 kg (264.6 lb) at screening.
- International normalised ratio (INR)>1.5 (unless participant is on anticoagulant therapy, in which case excluded if INR>3.5).
- Previous enrolment in this study.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section 10.4). Spain: For country-specific requirements, please refer to Appendix 8 (Section 10.8).
See the full eligibility criteria
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Completed study intervention in NN6019-4940 (a) and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. (a)- A participant who has not permanently discontinued study intervention as defined in NN6019-4940
- Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit.
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 2.5 × the upper limit of normal (ULN) or total bilirubin ≥ 2 × ULN at screening.
- Body weight > 120 kg (264.6 lb) at screening.
- International normalised ratio (INR)>1.5 (unless participant is on anticoagulant therapy, in which case excluded if INR>3.5).
- Previous enrolment in this study.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section 10.4). Spain: For country-specific requirements, please refer to Appendix 8 (Section 10.8).
- Use of another approved or non-approved investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (whichever is longer) before screening, except study intervention used in study NN6019-4940
- Participation (i.e., signed informed consent) in any interventional clinical study from visit 16 (week 64) in NN6019-4940 until visit 1 (screening) in the current study NN6019-7565.
- Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
- A prior solid organ transplant.
- Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia or low-grade prostate cancer) within 5 years before screening.
- Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Canada
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 Japan; United States; Canada. 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.