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

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
HYQVIA- Epoch 1 Participants receiving HYQVIA
  • Biological: HYQVIA
    Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
HYQVIA- Epoch 2 Participants with rHuPH antibody titers ≥160 (tested in Epoch 1)
  • Biological: HYQVIA
    Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461

More Details

NCT ID
NCT02593188
Status
Recruiting
Sponsor
Baxalta now part of Shire

Study Contact

Salvador Dominguez
+1-617-588-8347
Salvador.Dominguez@shire.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.