RECRUITING

TEGSEDI Pregnancy Surveillance Program

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.

Official Title

Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy

Quick Facts

Study Start:2020-01-15
Study Completion:2030-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04270058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
  2. 2. Able and willing to provide informed consent.
  3. 1. Have a diagnosis of hATTR-PN during pregnancy.
  4. 2. Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
  5. 3. Able and willing to provide informed consent.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ionis Pharmaceuticals
CONTACT
(844) 962-4787
ionisNCT04270058study@clinicaltrialmedia.com
Amy Miller, RPh, Pharm D.
CONTACT
877-465-7510
tegsedipregnancy@ubc.com

Study Locations (Sites)

TEGSEDI Pregnancy Coordinating Center
Morgantown, West Virginia, 26508
United States

Collaborators and Investigators

Sponsor: Akcea Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-15
Study Completion Date2030-11-15

Study Record Updates

Study Start Date2020-01-15
Study Completion Date2030-11-15

Terms related to this study

Keywords Provided by Researchers

  • Hereditary transthyretin amyloidosis with polyneuropathy
  • Hereditary transthyretin amyloidosis
  • hATTR
  • hATTR-PN
  • Rare disease

Additional Relevant MeSH Terms

  • Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
  • Pregnancy