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NCT02556775 · ClinicalTrials.gov registry record
Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia
A clinical trial, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- 16
- Enrollment target
NCT02556775: Completed study, sponsored by Baxalta now part of Shire.
NCT02556775 is a clinical trial that has completed, run by Baxalta now part of Shire. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02556775 has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily had a causal relationship with the treatment. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abn
Interventions
- BIOLOGICAL A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment
- BIOLOGICAL HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-12-04 |
| Est. Completion | 2019-12-17 |
What the finished NCT02556775 record still lists
NCT02556775 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment is the first listed.
NCT02556775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02556775 about?
NCT02556775 is a clinical study titled "Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia". 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.
What is the current status of trial NCT02556775?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2015-12-04. Estimated completion is 2019-12-17.
What interventions are being tested in trial NCT02556775?
The interventions under investigation include: A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment (BIOLOGICAL), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] (BIOLOGICAL).
Who is sponsoring clinical trial NCT02556775?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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