This is a global observational study of pregnancy exposures to TEGSEDI® (inotersen). The purpose of this study is to estimate the frequency of selected pregnancy outcomes and pregnancy complications from the TEGSEDI exposed and unexposed patients. Data collected from this study will be shared with the U.S. Food and Drug Administration (FDA) and may be added to the TEGSEDI labeling to provide prescribers with additional prescribing and consulting information.
Akcea is conducting a pregnancy program to collect and evaluate the effect of TEGSEDI on maternal pregnancy complications and outcomes, and on the health of infants exposed during pregnancy. The success of the study is dependent upon the participation of eligible patients and healthcare providers. Thank you for your time and consideration.
To enroll a patient or to request additional information:
If a patient is eligible for participation, she will be asked to read and sign an informed consent document containing details about the study and requesting to collect personal health information from healthcare providers involved in the care of her pregnancy and that of her infant.
Enrollment in the TEGSEDI-PRG Pregnancy Observational Study is entirely voluntary and may be initiated by healthcare providers with appropriate patient consent or pregnant women themselves. Women who were treated with at least 1 dose of TEGSEDI during their pregnancy or who became pregnant within 25 weeks of taking TEGSEDI are eligible. In addition, women with a diagnosis of hATTR-PN during pregnancy who have not been exposed to TEGSEDI during the pregnancy or within 25 weeks of conception are eligible.
Your patient's participation in the observational pregnancy study may last throughout her pregnancy and up to one year after her delivery date. Your patient will be contacted once per trimester, at the estimated date of delivery, and when her infant is 3, 6, 9, and 12 months of age to provide basic information about her pregnancy, post pregnancy health and her infant's health. At each time point, your patient will be asked to confirm her contact information.
A healthcare provider's (HCP) participation will vary depending on whether they are treating the patient or infant. The woman's obstetric HCP will be contacted between the 6th and 7th month of the patient's pregnancy and, again, within 4 weeks after the estimated delivery date. The pediatric HCP will be contacted when the baby is approximately 3, 6, 9, and 12 months old. In order to collect the information, The Pregnancy Coordinating Center will send questionnaires to the appropriate HCP for completion.
The Pregnancy Coordinating Center is responsible for collecting the study data. All data provided by you, other physicians, such as: the primary care doctor, obstetrician, pediatrician or neurologist, and/or your patient will be entered into the study database. The study database will be kept on a secure computer system maintained by the study administrator in accordance with their written security policy. Information about your health collected while you are in the TEGSEDI-PRG Pregnancy Observational Study will be kept anonymous and any identifying information will not be used.
The success of the TEGSEDI-PRG Pregnancy Observational Study depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and enrolling patients in the study, and in assisting with the collection of follow-up information during your patient's participation in the study.