Open Label Extension Study of AMG 531 in Japanese Subjects With ITP

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

July 31, 2011

Study Completion Date

September 30, 2011

Conditions
Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Interventions
BIOLOGICAL

AMG 531

AMG 531 will be administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG 531 is 10 μg/kg. AMG 531 will be supplied as a sterile, white, preservative-free, lyophilized powder in 5 mL glass vials containing 0.6 mg of protein per vial, and a protein concentration of 0.5 mg/mL when reconstituted with 1.2 mL of sterile water for injection.

Trial Locations (13)

060-8648

Research Site, Sapporo

305-8576

Research Site, Tsukuba

259-1193

Research Site, Isehara-shi

228-8555

Research Site, Sagamihara

565-0871

Research Site, Suita

409-3898

Research Site, Chūō

573-1191

Research Site, Hirakata

730-8619

Research Site, Hiroshima

860-8556

Research Site, Kumamoto

570-8507

Research Site, Moriguchi

113-8655

Research Site, Tokyo

141-8625

Research Site, Tokyo

160-8585

Research Site, Tokyo

All Listed Sponsors
lead

Kyowa Kirin Co., Ltd.

INDUSTRY

NCT00440037 - Open Label Extension Study of AMG 531 in Japanese Subjects With ITP | Biotech Hunter | Biotech Hunter