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

Baxalta

Status: Completed

Conditions: Exposure During Pregnancy

Treatments: Biological: HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]; Biological: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT02556775

161301

EUPAS5798 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• There are no applicable Exclusion Criteria

Trial design

16 participants in 2 patient groups

Alternative Product Arm

Description:

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.

Treatment:

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

HYQVIA Arm

Description:

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

Treatment:

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