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

Baxalta now part of Shire264 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

264

Conditions

Primary Immunodeficiency Diseases (PID)

Interventions

HYQVIABIOLOGICAL

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD) 2. Participant age is compatible with local package insert requirements 3. Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20) 4. Participant is willing and able to comply with the requirements of the protocol. 5. 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: 1. Participant has known hypersensitivity to any of the components of the medicinal product 2. 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 3. Participant is a family member or employee of the investigator 4. Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment