Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Exposure During Pregnancy
- Sponsor
- Baxalta now part of Shire
- Enrollment
- 16
- Locations
- 8
- Primary Endpoint
- Number of Participants With Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in women ever treated with HYQVIA. Development of the fetus/infant at birth and for the first 2 years will also be followed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For the expectant mother only: Participant became pregnant during or after treatment with HYQVIA
- •Participant/Participant's legally authorized representative is willing to sign an informed consent form (ICF)
Exclusion Criteria
- •There are no applicable Exclusion Criteria
Outcomes
Primary Outcomes
Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From start of study drug administration up to end of study (up to 48.4 months)
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily had a causal relationship with the treatment. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, is an important medical event. Number of participants with SAEs in expectant mothers and infants were reported.
Secondary Outcomes
- Number of Participants With Neonatal Assessment(At or after delivery/end of pregnancy (up to 40 weeks))
- Number of Participants With Status of the Infant at Birth(At or after delivery/end of pregnancy (up to 40 weeks))
- Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers(From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months))
- Number of Participants Who Experienced General Pregnancy Outcomes(Throughout the expectant mother pregnancy duration (up to 40 weeks))
- Number of Participants With Development Milestones(At 6, 12, 18 and 24 months follow-up)
- Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment(From start of study drug administration up to end of study (up to 48.4 months))
- Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers(From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months))
- Number of Participants With Antenatal Diagnostic Procedures(Throughout the expectant mother pregnancy duration (up to 40 weeks))
- Number of Participants With Growth Measurement and Charts for the Infant(At 6, 12, 18 and 24 months follow-up)