Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Knee Primary Osteoarthritis Who Are Candidates for Total Knee Replacement

PHASE1CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

April 30, 2010

Study Completion Date

June 30, 2010

Conditions
Knee Osteoarthritis
Interventions
DRUG

AS902330

3, 10, 30, 100 or 300 µg intra-articular injection per subject in the Single Ascending Dose (SAD) cohorts and 10, 30, 100, 300 µg or highest tolerated dose intra-articular injection per week for three weeks per subject in the Multiple Ascending Dose (MAD) cohorts.

DRUG

Placebo

Placebo or, 3, 10, 30, 100 or 300 µg intra-articular injection per subject in SAD cohorts and placebo or, 10, 30, 100, 300 µg or highest tolerated dose of AS902330 intra-articular injection per week for three weeks per subject in MAD cohorts.

Trial Locations (19)

Unknown

"UMHAT Sv. Ivan Rilski, Clinical Research Unit for Phase I", Sofia

Frederiksberg Hospital, Frederiksberg

Gentofte Hospital, Hellerup

Nordsjællands Hospital - Hørsholm, Hørsholm

Silkeborg sygehus, Silkeborg

Regionshospitalet Viborg, Viborg

Kuopio University Hospital, Kuopio

Oulu University Hospital, Oulu

Turku University Central Hospital, Turku

FARMOVS-PAREXEL (Pty) Ltd, University of the Free State, Bloemfontein

PAREXEL-George, George

PAREXEL-Port Elizabeth, Mercantile Hospital, Port Elizabeth

Sahlgrenska University Hospital/Östra, Gothenburg

Hässleholms Sjukhus, Hässleholm

Kungälv Sjukhus, Kungälv

Lund University Hospital, Lund

Malmö University Hospital, Malmo

Danderyds Sjukhus, Stockholm

Cambridge University Hospitals, Cambridge

All Listed Sponsors
collaborator

Merck Serono S.A., Geneva

INDUSTRY

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00911469 - Study of AS902330 (rhFGF-18) Administered Intra-articularly in Patients With Knee Primary Osteoarthritis Who Are Candidates for Total Knee Replacement | Biotech Hunter | Biotech Hunter