Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Purpose
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.
Condition
- Primary Immunodeficiency Diseases (PID)
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| HYQVIA- Epoch 1 | Participants receiving HYQVIA |
|
| HYQVIA- Epoch 2 | Participants with rHuPH antibody titers ≥160 (tested in Epoch 1) |
|
More Details
- Status
- Completed
- Sponsor
- Baxalta now part of Shire