drugset / Trial / NCT05338047
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.
Timeline
- Start
- 2022-04-01
- Primary completion
- 2023-02-25
- Completion
- 2023-02-25
Publications
- Results Jagasia MH, Greer JP, Morgan DS, Mineishi S, Kassim AA, Ruffner KL, Chen H, Schuening FG. Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9. doi: 10.1038/sj.bmt.1704994.
- Results Sheth V, Gore A, Jain R, Ghanekar A, Saikia T. Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant. Indian J Hematol Blood Transfus. 2019 Jan;35(1):66-71. doi: 10.1007/s12288-018-0966-5. Epub 2018 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |