RecruitingOBSERVATIONAL

Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program

This study is tracking pregnancies in women who have come into contact with a medicine called patisiran-LNP, which is used to treat a condition called hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy. The main goal is to collect and check information about how these pregnancies progress, any problems that might occur during pregnancy, and the health of the babies born to these mothers. By carefully recording these details, researchers hope to gain a better understanding of the possible effects of patisiran-LNP exposure on both mothers and their children. This information is important for improving our knowledge about the medicine and ensuring the best care for patients.

At a glance

Status

Recruiting

Sponsor

Alnylam Pharmaceuticals

Enrolment target

Start

01 Aug 2020

Estimated completion

12 Oct 2030

Hereditary Transthyretin-mediated (hATTR) Amyloidosis Polyneuropathy

What is this study about?

This programme is designed to carefully watch and collect information from pregnant women who have been exposed to a medicine called patisiran-LNP. This medicine is used to treat a serious condition called hereditary ATTR amyloidosis, which can cause nerve damage (polyneuropathy). Because pregnancy can be a sensitive time, it's very important to understand how any medicines might affect both the mother and the developing baby.

The main purpose of this programme is to gather details about the pregnancy itself – whether everything goes smoothly or if there are any difficulties. It also looks at the health of the baby, from birth through their early life. By collecting all this information, doctors and researchers can learn more about how patisiran-LNP might impact pregnancy outcomes.

This study matters because it helps us build a clearer picture of the safety of patisiran-LNP during pregnancy. This knowledge can then be used to provide better advice and care for women with hereditary ATTR amyloidosis who may become pregnant or are pregnant while taking this medication. It’s all about making sure patients get the safest and most effective treatment possible.

Key takeaways

This programme gathers information on pregnancies where the mother was exposed to patisiran-LNP.
It aims to understand pregnancy outcomes, complications, and baby's health.
Participation will help improve knowledge about patisiran-LNP use during pregnancy.
There are no medical interventions or changes to your treatment involved.
Your privacy and medical care will not be affected by your decision to participate or withdraw.

Who may be eligible?

This programme is for any woman who has been exposed to the medicine patisiran-LNP, either in the 12 weeks leading up to her last period before pregnancy, or at any point during her pregnancy.

There are no other specific requirements or conditions that would prevent someone from taking part. If you fit the description above, you can be included in this programme.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a woman.
I am currently pregnant or was pregnant.
I was exposed to patisiran-LNP during my pregnancy.
I was exposed to patisiran-LNP in the 12 weeks before my last period.

Answer every question to see your result.

What does participation involve?

If you take part in this programme, it simply involves providing information about your pregnancy and your baby's health to your healthcare team. There are no extra hospital visits or special assessments. You won't be given any new medication as part of this programme, and you won't need to change any existing treatment. The programme will follow up on your pregnancy outcomes and your baby's health in their early life. The total duration of your participation will depend on how long it takes to collect all the necessary information about your pregnancy and your baby.

Potential risks and benefits

The main benefit of taking part in this programme is that the information you provide will help doctors and researchers understand more about how patisiran-LNP affects pregnancy and babies. This knowledge is crucial for guiding future medical care and ensuring the safety of other patients. There are no direct medical benefits to you personally, as it's an observation programme. There are also no known medical risks associated with simply providing this information. You are free to withdraw from this programme at any time without it affecting your medical care.

Locations (7)

Clinical Trial Site
Verified postcode
Iowa City, United States· Recruiting
Clinical Trial Site
Verified postcode
Nantes, France· Recruiting
Clinical Trial Site
Verified postcode
Münster, Germany· Recruiting
Clinical Trial Site
Verified postcode
Pavia, Italy· Recruiting
Clinical Trial Site
Verified postcode
Groningen, Netherlands· Recruiting
Clinical Trial Site
Verified postcode
Lisbon, Portugal· Recruiting
Clinical Trial Site
Verified postcode
Madrid, Spain· Recruiting

Common questions

What is the study trying to find out?

It wants to learn how exposure to patisiran-LNP affects pregnant women and their babies.

Do I need to take extra medicine?

No, you don't take any extra medicine for this programme. It's just about collecting information.

What condition are they looking at?

The focus is on women with hereditary ATTR amyloidosis who have been exposed to patisiran-LNP.

Will this programme change my current treatment?

No, participation in this information-gathering programme will not change your current medical treatment.

Can I stop taking part if I change my mind?

Yes, you can decide to stop being part of the programme at any time, and it won't affect your care.

How to find out more

Alnylam Clinical Trial Information Line

clinicaltrials@alnylam.com 1-877-ALNYLAM Official trial record

Always speak to your GP or specialist before deciding to take part in a study.