Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

Baxalta

Status

Completed

Conditions

Primary Immunodeficiency Diseases (PID)

Treatments

Biological: HYQVIA

Study type

Observational

Funder types

Industry

Identifiers

NCT02593188

161406

EUPAS21523 (Registry Identifier)

Details and patient eligibility

About

The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.

Enrollment

264 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
Participant age is compatible with local package insert requirements
Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
Participant is willing and able to comply with the requirements of the protocol.
Female participant of child-bearing potential agrees to inform the investigator if she becomes pregnant, or plans to become pregnant during the course of the study

Exclusion criteria

Participant has known hypersensitivity to any of the components of the medicinal product
Participant has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study
Participant is a family member or employee of the investigator
Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment