Efficacy and Safety Study of CSJ148 in Stem Cell Transplant Patients

Summary

This study is designed to test if CSJ148 can prevent HCMV replication after stem cell transplantation.

Timeline

Start

2015-06-02

Primary completion

2016-12-07

Completion

2016-12-07

Outcome

Missed primary endpoint

paper The primary efficacy endpoint was therefore not met, indicating that CSJ148 did not prevent clinically significant HCMV reactivation in recipients of allogeneic hematopoietic cell transplants. PMID 32015031 ↗

Publications

• Maertens J, Logan AC, Jang J, Long G, Tang JL, Hwang WYK, Koh LP, Chemaly R, Gerbitz A, Winkler J, Yeh SP, Hiemenz J, Christoph S, Lee DG, Wang PN, Holler E, Mielke S, Akard L, Yeo A, Ramachandra S, Smith K, Pertel P, Segal F. Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e02467-19. doi: 10.1128/AAC.02467-19. Print 2020 Mar 24.

Drugs

Indications