Trials / Withdrawn
WithdrawnNCT03385395
Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency
A Randomized, Double-blind, Parallel-group, Multicenter, Pharmacokinetic Study Comparing Weekly Intravenous Administration of OctaAlpha1 (Octapharma) With a Marketed Preparation Glassia® (Kamada Ltd.) in Subjects With Alpha-1-antitrypsin Deficiency
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized trial is being conducted to show non-inferiority of OctaAlpha1 compared to Glassia® in terms of the serum trough levels at steady state. This will be conducted in individuals with alpha-1-antitrypsin deficiency and clinical evidence of emphysema.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OctaAlpha1 | For OctaAlpha1 the standard weekly dose of 60mg/kg will be given for 24 consecutive infusions |
| DRUG | Glassia | For Glassia the standard weekly dose of 60mg/kg will be given for 24 consecutive infusions |
Timeline
- Start date
- 2018-07-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2017-12-28
- Last updated
- 2018-04-10
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03385395. Inclusion in this directory is not an endorsement.