| Trial ID: | L1659 |
| Source ID: | NCT02502903
|
| Associated Drug: |
Biv009
|
| Title: |
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
|
| Acronym: |
BIVV009-01
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Bullous Pemphigoid (BP)|Cold Agglutinin Disease (CAD)|Warm Autoimmune Hemolytic Anemia (WAIHA)|End-stage Renal Disease (ESRD)
|
| Interventions: |
DRUG: BIV009|OTHER: Placebo
|
| Outcome Measures: |
Primary: Drug-related Adverse Event profile of BIVV009, Serious and Non-Serious adverse events probably or possibly attributable to BIVV009, 6 weeks | Secondary: Pharmacokinetic profile of BIVV009, Tmax, Cmax, Area under curve (AUC) and T1/2, 6 weeks|Classical pathway complement system activity, inhibition by BIVV009 of the complement system classical pathway measured by the WIESLAB® assay, 6 weeks|Complement System-Related biomarkers, e.g. CH50, 6 weeks|Coagulation System-Related biomarkers, e.g. Fibrin D-dimer, 6 weeks|Disease-Related Biomarkers, e.g. Haptoglobin, 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Bioverativ, a Sanofi company | Collaborators: Celerion Clinical Research GmbH|Assign Data Management and Biostatistics GmbH|ABF Pharmaceutical Services GmbH|Quest Diagnostics-Nichols Insitute|Covance|PPD Laboratories - Virginia|Softworld Inc. - Cambridge, MA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
122
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-07-13
|
| Completion Date: |
2021-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-25
|
| Locations: |
Medical University of Vienna, Vienna, 1090, Austria
|
| URL: |
https://clinicaltrials.gov/show/NCT02502903
|
