This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
MIV-711 administered orally once daily
MC Comac Medical
Sofia, Bulgaria
LCC ARENSIA Exploratory Medicine
Tbilisi, Georgia
PAREXEL Berlin Early Phase Clinical Unit
Berlin, Germany
LCC ARENSIA Exploratory Medicine
Chisinau, Moldova
Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) 2. Number of Participants with Serious Adverse Events (SAEs) 3. Number of Participants with TEAEs related to treatment 4. Number of Participants with mild TEAEs 5. Number of Participants with moderate TEAEs 6. Number of Participants with severe TEAEs 7. Number of Participants with TEAEs leading to early discontinuation
Time frame: Group A: 0-56 weeks; Group B: 0-30 weeks
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