Trials / Terminated
TerminatedNCT02093221
Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
A Multicenter, Randomized, Partial-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Grifols Therapeutics LLC · Industry
- Sex
- All
- Age
- 6 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, partial-blinded, five-arm, placebo-controlled study of human plasma-derived alpha1-proteinase inhibitor (alpha1-PI) in children (ages 6-11 years old) and teens/adults (ages 12-35 years old) with new onset Type 1 Diabetes Mellitus (T1DM). Currently enrolling ages 12-35 only. Once 25 patients are randomized and data is reviewed enrollment will be opened to the child cohort. The purpose of this study is to evaluate the safety and efficacy of four dosing regimens of human plasma-derived alpha1-PI in T1DM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 180 mg/kg Alpha1-PI | |
| BIOLOGICAL | 90 mg/kg Alpha1-PI | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2017-01-01
- Completion
- 2017-06-01
- First posted
- 2014-03-20
- Last updated
- 2018-09-05
- Results posted
- 2018-04-19
Locations
36 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02093221. Inclusion in this directory is not an endorsement.