Clinical trial NCT02556775: Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
Official title: Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure During Pregnancy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxalta Innovations GmbH, now part of Shire
First posted: 2015-09-22
Enrollment: 16
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who became pregnant after ever treated with HYQVIA, and their infant children

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.


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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From start of study drug administration up to end of study (up to 48.4 months)
Secondary outcomes:
measure: Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
timeFrame: From start of study drug administration up to end of study (up to 48.4 months)
measure: Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers
timeFrame: From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)
measure: Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers
timeFrame: From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)
measure: Number of Participants With Antenatal Diagnostic Procedures
timeFrame: Throughout the expectant mother pregnancy duration (up to 40 weeks)
measure: Number of Participants Who Experienced General Pregnancy Outcomes
timeFrame: Throughout the expectant mother pregnancy duration (up to 40 weeks)
measure: Number of Participants With Neonatal Assessment
timeFrame: At or after delivery/end of pregnancy (up to 40 weeks)
measure: Number of Participants With Status of the Infant at Birth
timeFrame: At or after delivery/end of pregnancy (up to 40 weeks)
measure: Number of Participants With Growth Measurement and Charts for the Infant
timeFrame: At 6, 12, 18 and 24 months follow-up
measure: Number of Participants With Development Milestones
timeFrame: At 6, 12, 18 and 24 months follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: QuintilesIMS Plaza Building
state: North Carolina
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Freiburg
country: Germany
facility: Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher
state: Baden-Württemberg
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
state: Bayern
city: Leipzig
country: Germany
facility: Klinikum St. Georg GmbH
state: Sachsen
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
city: Bratislava
country: Slovakia
facility: Onkologicky ustav svatej Alzbety s.r.o.
city: Kosice
country: Slovakia
facility: RAFMED s.r.o
Study officials:
affiliation: Shire
name: Shire Director
role: STUDY_DIRECTOR
References:
citation: Borte M, Raffac S, Hrubisko M, Jahnz-Rozyk K, Garcia E, McCoy B, Chavan S, Nagy A, Yel L. Long-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study. Immunotherapy. 2022 Jun;14(8):609-616. doi: 10.2217/imt-2021-0336. Epub 2022 Apr 20.