NCT02556775|CompletedResults
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Sponsor study identifier
Secondary identifiers
REGISTRY · EU PAS Register
observational
16
5 countries
8
Study Start
December 4, 2015
Actual (reported)Primary Completion
December 17, 2019
Actual (reported)Study Completion
December 17, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 17, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2015
Actual (reported)September 22, 2015
Actual (reported)December 4, 2015
Actual (reported)December 17, 2019
Actual (reported)December 17, 2019
Actual (reported)April 28, 2021
Actual (reported)Number of Participants With Serious Adverse Events (SAEs)
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.
From start of study drug administration up to end of study (up to 48.4 months)
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 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 With Antenatal Diagnostic Procedures
Throughout the expectant mother pregnancy duration (up to 40 weeks)
Number of Participants Who Experienced General Pregnancy Outcomes
Throughout the expectant mother pregnancy duration (up to 40 weeks)
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.
Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen.
To be determined by the physician
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Women who became pregnant after ever treated with HYQVIA, and their infant children
QuintilesIMS Plaza Building
Durham, North Carolina, 27703, United States
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034, Czechia
Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher
Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080, Germany
Klinikum St. Georg GmbH
Leipzig, Saxony, 04129, Germany
Wojskowy Instytut Medyczny
Warsaw, 04-141, Poland
Onkologicky ustav svatej Alzbety s.r.o.
Bratislava, 81250, Slovakia
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.
Blood samples (plasma) for anti-recombinant human hyaluronidase (rHuPH20) antibodies that remain after study testing is done may be stored and used for additional testing (eg, further evaluation of an abnormal test or an adverse event). Samples will be stored in a coded form for a maximum of 2 years after the final study report has been completed and, subsequently, will be destroyed.
Shire Director
Shire
16 participants (actual enrollment reported by the registry).
First Submitted
June 26, 2015
First Posted
September 22, 2015
Study Start
December 4, 2015
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
RAFMED s.r.o
Košice, 04001, Slovakia
Primary Completion
December 17, 2019
Actual (reported)Study Completion
December 17, 2019
Actual (reported)Last Updated
April 28, 2021
Results First Posted
April 28, 2021
Record last verified: 2021-04
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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