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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-04

Study Completion Date

2019-12-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Exposure During Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type BIOLOGICAL

To be determined by the physician

HYQVIA Arm

Participant continues to receive HYQVIA (Immune Globulin (Human) 10% with recombinant human hyaluronidase (rHuPH20)), according to her treatment regimen.

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

Intervention Type BIOLOGICAL

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

Interventions

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

To be determined by the physician

Intervention Type BIOLOGICAL

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

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Hyqvia

Eligibility Criteria

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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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No