Trials / Withdrawn
WithdrawnNCT03492710
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Green Cross Corporation · Industry
- Sex
- All
- Age
- 24 Months – 203 Months
- Healthy volunteers
- Not accepted
Summary
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immunoglobulin | Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more |
Timeline
- Start date
- 2019-04-30
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
- First posted
- 2018-04-10
- Last updated
- 2020-07-07
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03492710. Inclusion in this directory is not an endorsement.