RECRUITING

A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

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Conditions

Phenylketonuria, MaternalPhase 4ObservationalMaternalPregnancy OutcomesExposureBreastfeeding Outcomes

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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 Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.

Official Title

A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding

Quick Facts

Study Start:2022-11-22
Study Completion:2032-10-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05579548

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:Not specified
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject (or a legally authorized representative) consent obtained prior to enrollment. Consent will be obtained in compliance with any country-specific regulations or requirements
  2. * Confirmation of ongoing pregnancy. Subjects with unknown outcomes will be classified as prospective pregnancies; subjects who have undergone prenatal testing (eg, targeted ultrasound, amniocentesis) regardless of findings will be classified as retrospective pregnancies
  3. * Diagnosed with PKU per local standard of care
  4. * Documentation that the subject was treated with pegvaliase at any point starting from 2 weeks prior to the date of LMP
  5. * Agrees to permit the Investigator (ie, CRP, CCA, PI) to contact the subject's HCPs (eg, PCP, PKU-treating physician, OB, nurse, midwife) and the infant's HCP (eg, pediatrician, neonatologist) for medical information
  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

165-504 Program Director
CONTACT
1-800-983-4587
medinfo@bmrn.com

Principal Investigator

Medical Director, MD
STUDY_DIRECTOR
BioMarin Pharmaceutical

Study Locations (Sites)

Syneos Health
Wilmington, North Carolina, 28403
United States

Collaborators and Investigators

Sponsor: BioMarin Pharmaceutical

  • Medical Director, MD, STUDY_DIRECTOR, BioMarin Pharmaceutical

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 Date2022-11-22
Study Completion Date2032-10-04

Study Record Updates

Study Start Date2022-11-22
Study Completion Date2032-10-04

Terms related to this study

Keywords Provided by Researchers

  • Phase 4
  • Observational
  • Maternal
  • Pregnancy Outcomes
  • Exposure
  • Breastfeeding Outcomes

Additional Relevant MeSH Terms

  • Phenylketonuria, Maternal