Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia

Completed

Conditions: Exposure During Pregnancy

Interventions: Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment

Registration Number: NCT02556775

Lead Sponsor: Baxalta now part of Shire

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 16

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HYQVIA Arm	HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]	Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen.
Alternative Product Arm	A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment	Participant stops HYQVIA treatment (if the participant is still treated) and a licensed human normal immunoglobulin other than HYQVIA for intravenous (IV) or subcutaneous (SC) infusion or an alternative treatment will be administered, as determined by the physician.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events (SAEs)	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 Outcome Measures

Name	Time	Method
Number of Participants With Neonatal Assessment	At or after delivery/end of pregnancy (up to 40 weeks)	Neonatal assessment included parameters like weight, length, head circumference, Apgar scores, pulse rate, blood pressure, respiratory rate, body temperature with normal, abnormal and missing status. The Apgar scores was determined by evaluating the newborn baby on five simple criteria: Appearance, Pulse, Grimace, Activity, Respiration: on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.
Number of Participants With Status of the Infant at Birth	At or after delivery/end of pregnancy (up to 40 weeks)	Status of the infant at birth included the following as: Any need for resuscitation of the infant, Admission in intensive care unit, Presence of congenital malformations/anomaly, Any other conditions noted at or around birth with status yes, no and unknown.
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 developed positive \[titer ≥160\] of anti-rHuPH20 binding in expectant mothers were reported. Neutralizing antibodies were assessed if the binding antibody assay has a result of 160 or above.
Number of Participants Who Experienced General Pregnancy Outcomes	Throughout the expectant mother pregnancy duration (up to 40 weeks)	Pregnancy outcomes included live birth, fetal death, termination or unknown.
Number of Participants With Development Milestones	At 6, 12, 18 and 24 months follow-up	Developmental milestones evaluation included rolled over, attended to and reached for objects, sat up without support, turned to locate a voice, said his/her first words, and stand without support/help. Number of participants with development milestones at 6, 12, 18 and 24 months follow-up was reported.
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)	An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with the treatment. Number of participants with Non-SAEs, related and not related to HyQvia/Human Normal IG or alternative treatment in expectant mothers and infants were reported.
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)	AESI were AEs that were considered by the sponsor to be relevant for the monitoring of the safety profile. AESI's included in this study were local/immunologic AEs including skin changes (Such as, local erythema, local pruritus, induration, nodules). Number of participants with AESIs in expectant mother were reported.
Number of Participants With Antenatal Diagnostic Procedures	Throughout the expectant mother pregnancy duration (up to 40 weeks)	Antenatal diagnostic procedures included ultrasound, serology and nuchal translucency screen which are used to assess the Fetal growth/development. Number of participants reported fetal growth/development were recorded.
Number of Participants With Growth Measurement and Charts for the Infant	At 6, 12, 18 and 24 months follow-up	Growth measurement and charts for the infant was assessed based on following parameters: Any congenital malformations diagnosed that were not reported at birth, any conditions that were noted since birth, weight assessment, length assessment, head circumference assessment. Number of participants with growth measurement and charts for the infant at 6, 12, 18 and 24 months follow-up was reported.

Trial Locations

Locations (8): Onkologicky ustav svatej Alzbety s.r.o.
🇸🇰
Bratislava, Slovakia
QuintilesIMS Plaza Building
🇺🇸
Durham, North Carolina, United States
Universitaetsklinikum Wuerzburg
🇩🇪
Würzburg, Bayern, Germany
Klinikum St. Georg GmbH
🇩🇪
Leipzig, Sachsen, Germany
Wojskowy Instytut Medyczny
🇵🇱
Warszawa, Poland
RAFMED s.r.o
🇸🇰
Kosice, Slovakia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿
Praha 10, Czechia
Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher
🇩🇪
Freiburg, Baden-Württemberg, Germany