Trials / Completed
CompletedNCT02556775
Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 16 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment | To be determined by the physician |
| BIOLOGICAL | HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] | Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
Timeline
- Start date
- 2015-12-04
- Primary completion
- 2019-12-17
- Completion
- 2019-12-17
- First posted
- 2015-09-22
- Last updated
- 2021-04-28
- Results posted
- 2021-04-28
Locations
8 sites across 5 countries: United States, Czechia, Germany, Poland, Slovakia
Source: ClinicalTrials.gov record NCT02556775. Inclusion in this directory is not an endorsement.