Pregnancy Registry to collect Long-Term Safety Data from Women treated with HyQvia

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, uncontrolled, two-arm, open-label, multicenter post-authorization study

Study drug and medical condition

• Name of medicine:
  HYQVIA
• Medical condition to be studied:
  Exposure during pregnancy

Population studied

• Short description of the study population:
  Inclusion criteria; Subjects who met all of the following criteria were eligible for this study:; • For the expectant mother only: Subject became pregnant during or after treatment with HyQvia; • Subject/subject’s legally authorized representative was willing to sign informed consent form (ICF) ; ; Exclusion criteria; There were no applicable exclusion criteria for this registry.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  20

Study design details

• Main study objective:
  To collect and assess clinical safety data regarding the possible effects of HyQvia on the course and outcome of the pregnancy, and on the growth and development of the fetus/infant exposed to HyQvia in utero.
• Outcomes:
  The incidence of all serious adverse events (SAEs), 1. Incidence of non-SAEs 2. Incidence of local/immunologic AEs 3. Development of anti-rHuPH20 antibodies 4. Complications of pregnancy 5. Fetal growth/development 6. Outcome of pregnancy 7. Neonatal assessment according to clinical practice 8. Status of the infant at birth 9. Growth measurement and charts for the infant 10. Development milestones determined by standard test methods
• Data analysis plan:
  Statistical analyses and data displays will be descriptive. Data from all enrolled subjects will be included in the analyses. Retrospective reports and prospective reports are clearly labeled. It will be considered to analyze them separately. All SAEs, non-serious AEs and other types of safety data will be categorized according to MedDRA system organ class (SOC) and preferred term, as far as possible. Tables will be prepared to list for each SAE, non-serious AE and other type of safety data, the number of events/data, and the number of subjects who experienced one or more events. Outcome measures regarding pregnancy loss, stillbirth, and congenital abnormalities, will be compared to published data for the region and, if known, for the specific patient population. Growth and development of the infant will be compared to growth parameters for the specific region, as appropriate, if available, or else to standard published charts.

Documents

Study results

161301-clinical-study-report-redact