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

NCT02556775 | Completed Results

• 2 other identifiers: 161301EUPAS5798
• Study Type: observational
• Target: 16
• Locations: 5 countries
• Sites: 8

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.

Conditions

Exposure During Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 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

  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)

Study Arms (2)

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.

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.

Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]

Interventions

A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment BIOLOGICAL

To be determined by the physician

Alternative Product Arm

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] BIOLOGICAL

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Also known as: Hyqvia

HYQVIA Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who became pregnant after ever treated with HYQVIA, and their infant children

You may qualify if:

• 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)

Sponsors & Collaborators

• Baxalta now part of Shire: lead
• Baxalta Innovations GmbH, now part of Shire: collaborator

Study Sites (8)

QuintilesIMS Plaza Building

Durham, North Carolina, 27703, United States

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Klinikum St. Georg GmbH

Leipzig, Saxony, 04129, Germany

Location

Wojskowy Instytut Medyczny

Warsaw, 04-141, Poland

Location

Onkologicky ustav svatej Alzbety s.r.o.

Bratislava, 81250, Slovakia

Location

RAFMED s.r.o

Košice, 04001, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 35443783 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Shire Director

  Shire

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 33 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: September 22, 2015
• Study Start: December 4, 2015
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: April 28, 2021
• Results First Posted: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

DE (3); SL (2); PL (1); CZ (1); US (1)