Trials / Terminated
TerminatedNCT03686969
Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis
Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Dermatomyositis (SCGAM-02)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Octanorm | Octanorm 0.5g/kg/week |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2018-08-02
- Primary completion
- 2018-11-22
- Completion
- 2018-11-29
- First posted
- 2018-09-27
- Last updated
- 2021-04-23
- Results posted
- 2021-04-23
Locations
1 site across 1 country: Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03686969. Inclusion in this directory is not an endorsement.