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

Conditions

• Primary Immunodeficiency Diseases (PID)

Eligibility Criteria

Sex

ALL

Age

16 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• HYQVIA — BIOLOGICAL
  Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Study Details

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.

Key Dates

First listed

Nov 2, 2015

Start date

Nov 12, 2015

Status verified

Oct 2022

Primary completion

Oct 21, 2021

Completion

Oct 21, 2021

Study Design

Enrollment

264 participants (actual)

Arms

• Arm: HYQVIA- Epoch 1
  Participants receiving HYQVIA
• Arm: HYQVIA- Epoch 2
  Participants with rHuPH antibody titers ≥160 (tested in Epoch 1)

Primary Outcome Measure

Incidence of all related serious adverse events (SAEs) [ Time Frame: Throughout the study period of approximately 5 1/2 years ]

Locations (30)

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