N/A
Completed N=16
Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
Exposure During Pregnancy
Source: ClinicalTrials.gov NCT02556775 ↗
Enrolled (actual)
16
Serious AEs
18.8%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) — 0; 1; 1; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
0; 1; 1; 1 | — |
| SECONDARY Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment |
2; 2; 4; 1; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers |
0; 0 | — |
| SECONDARY Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers |
0; 0 | — |
| SECONDARY Number of Participants With Antenatal Diagnostic Procedures |
3; 0; 2; 0; 1; 0 | — |
| SECONDARY Number of Participants Who Experienced General Pregnancy Outcomes |
6; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Neonatal Assessment |
5; 2; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Status of the Infant at Birth |
0; 0; 5; 2; 0; 0 | — |
| SECONDARY Number of Participants With Growth Measurement and Charts for the Infant |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Development Milestones |
0; 0; 1; 1; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02556775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.