Exposure During PregnancyNCT02556775
Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
An observational study of Exposure During Pregnancy, run by Baxalta now part of Shire at 8 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Exposure During Pregnancy
- What is being tested?
- A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment and HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 4 Dec 2015to 17 Dec 2019
- How long will I take part?
- 33 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who became pregnant after ever treated with HYQVIA, and their infant children
Who may be able to join
- 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)
Who cannot join
- There are no applicable Exclusion Criteria
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany3 sites
Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher
Freiburg im Breisgau, Baden-Wurttemberg, 79108
Klinikum St. Georg GmbH
Leipzig, Saxony, 04129
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080
Slovakia2 sites
Onkologicky ustav svatej Alzbety s.r.o.
Bratislava, 81250
RAFMED s.r.o
Košice, 04001
United States1 site
QuintilesIMS Plaza Building
Durham, North Carolina, 27703
About this study
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.
- Conditions
- Exposure During Pregnancy
- Being tested
- A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatmentBiological
To be determined by the physician
HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]Biological
Also called Hyqvia
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
| Study group | Role | What they receive |
|---|---|---|
| Alternative Product Arm | 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. Receives: Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment | |
| HYQVIA Arm | Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen. Receives: Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of study drug administration up to end of study (up to 48.4 months)
Secondary outcomes (9)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Throughout the expectant mother pregnancy duration (up to 40 weeks)
Number of Participants Who Experienced General Pregnancy Outcomes
Pregnancy outcomes included live birth, fetal death, termination or unknown.
Measured: Throughout the expectant mother pregnancy duration (up to 40 weeks)
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.
Measured: At or after delivery/end of pregnancy (up to 40 weeks)
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.
Measured: At or after delivery/end of pregnancy (up to 40 weeks)
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.
Measured: At 6, 12, 18 and 24 months follow-up
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.
Measured: At 6, 12, 18 and 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start4 Dec 2015
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exposure During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
- Target duration
- 33 Months
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire
- Responsible party
- Sponsor
- Investigators
- Shire Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556775
- Sponsor's protocol ID
- 161301
- Other IDs
- EUPAS5798
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2015
- Last updated
- 28 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35443783
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
- ClinicalTrials.gov ID
- NCT02556775
- Acronym / sponsor ID
- 161301
- Conditions
- Exposure During Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire
- Study start
- 4 Dec 2015 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 33 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Product Arm | – | Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatmentParticipant 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. |
| HYQVIA Arm | – | Biological: 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who became pregnant after ever treated with HYQVIA, and their infant children
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- There are no applicable Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatmentTo be determined by the physician | Biological | Alternative Product Arm |
| HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]Also: HyqviaImmune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase | Biological | HYQVIA Arm |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs)
Time frame: 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.
9 secondary outcomes
Number of Participants With Non-serious Adverse Events (Non-SAEs), Related and Not Related to HyQvia/Human Normal Immunoglobulin (IG) or Alternative Treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Throughout the expectant mother pregnancy duration (up to 40 weeks)
Number of Participants Who Experienced General Pregnancy Outcomes
Time frame: Throughout the expectant mother pregnancy duration (up to 40 weeks)
Number of Participants With Neonatal Assessment
Time frame: At or after delivery/end of pregnancy (up to 40 weeks)
Number of Participants With Status of the Infant at Birth
Time frame: At or after delivery/end of pregnancy (up to 40 weeks)
Number of Participants With Growth Measurement and Charts for the Infant
Time frame: At 6, 12, 18 and 24 months follow-up
Number of Participants With Development Milestones
Time frame: At 6, 12, 18 and 24 months follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35443783Borte 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shire Director study director
Shire
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure During Pregnancy, run by Baxalta now part of Shire at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Slovakia, United States, Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) (time frame: From start of study drug administration up to end of study (up to 48.4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.