Clinical Trials | M.A.G.I.C. Clinic Canada
Pegvalaise
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (pegvaliase) During Pregnancy and Breastfeeding.
About the study
This is an observational, prospective surveillance study of subjects with PKU exposed to pegvaliase during pregnancy. No study medication is provided as part of participation and all direction for medication usage is at the discretion of the prescribing physician in accordance with standard practice and the local label.
Purpose:
- This study will help doctors learn more about the safety of using Palynziq® during pregnancy and breastfeeding.
Enrolment criteria
- Diagnosis with PKU per local standard of care
- You may qualify for the study if you have taken Palynziq® at any time during your pregnancy.
What to expect
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information
- There are no additional healthcare provider visits, testing, or treatments beyond the regular medical care you receive from your healthcare provider(s).
- With your consent, your healthcare provider(s) and your baby’s healthcare provider(s) will be contacted to obtain information at various times about you, your pregnancy, and your baby through their first year of life.
- If you are breastfeeding, information about your Palynziq® prescription will be collected for up to 12 months after your baby is born. We will also collect information about your experience with Palynziq.
For more information contact the M.A.G.I.C. Clinic
Ask your doctor if you qualify to participate in this observational safety study.
+1 (587) 885-3158