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

Exposure During Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556775
• Other study ID #: 161301
• Secondary ID: EUPAS5798
• Status: Completed
• Start date: December 4, 2015
• Est. completion date: December 17, 2019

Study information

• Verified date: April 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Exposure During Pregnancy

Intervention

Biological:
• A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment
To be determined by the physician
• HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Locations

Country	Name	City	State
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Germany	Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher	Freiburg	Baden-Württemberg
Germany	Klinikum St. Georg GmbH	Leipzig	Sachsen
Germany	Universitaetsklinikum Wuerzburg	Würzburg	Bayern
Poland	Wojskowy Instytut Medyczny	Warszawa
Slovakia	Onkologicky ustav svatej Alzbety s.r.o.	Bratislava
Slovakia	RAFMED s.r.o	Kosice
United States	QuintilesIMS Plaza Building	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Baxalta now part of Shire	Baxalta Innovations GmbH, now part of Shire

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment	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.	From start of study drug administration up to end of study (up to 48.4 months)
Secondary	Number of Participants With Adverse Event of Special Interests (AESIs) in Expectant Mothers	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.	From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)
Secondary	Number of Participants Who Developed Anti-rHuPH20 Antibodies in Expectant Mothers	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.	From start of first mother enrollment up to last mother's completion/discontinuation of study (up to 29.1 months)
Secondary	Number of Participants With Antenatal Diagnostic Procedures	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.	Throughout the expectant mother pregnancy duration (up to 40 weeks)
Secondary	Number of Participants Who Experienced General Pregnancy Outcomes	Pregnancy outcomes included live birth, fetal death, termination or unknown.	Throughout the expectant mother pregnancy duration (up to 40 weeks)
Secondary	Number of Participants With Neonatal Assessment	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.	At or after delivery/end of pregnancy (up to 40 weeks)
Secondary	Number of Participants With Status of the Infant at Birth	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.	At or after delivery/end of pregnancy (up to 40 weeks)
Secondary	Number of Participants With Growth Measurement and Charts for the Infant	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.	At 6, 12, 18 and 24 months follow-up
Secondary	Number of Participants With Development Milestones	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.	At 6, 12, 18 and 24 months follow-up