Trials / Completed
CompletedNCT00627146
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- All
- Age
- 12 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration. The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ChAgly CD3 | 6 days treatment 8mg/d intravenous |
| DRUG | Placebo | 6 days |
Timeline
- Start date
- 2000-06-01
- Primary completion
- 2007-03-01
- Completion
- 2007-03-01
- First posted
- 2008-02-29
- Last updated
- 2008-09-29
Locations
5 sites across 2 countries: Belgium, Germany
Source: ClinicalTrials.gov record NCT00627146. Inclusion in this directory is not an endorsement.