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Clinical Trial Summary

This phase IIB, open-label, multicenter study evaluated the efficacy and safety of oral Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis and Previously Treated With Ruxolitinib. The experiment is divided into two parts: dose exploration and extended research.


Clinical Trial Description

dose exploration: It is planned to enroll about 6 subjects. According to the baseline value of platelet count at the time of enrollment, different doses (100mg Qd or 150mg Qd or 200mg Qd or 100mg Bid) of Jaktinib Hydrochloride Tablets will be Treated. The trial is in progress Adjust the dose according to relevant laboratory indicators. When at least one subject has a spleen volume reduction of ≥35% from the baseline, the sponsor and the investigator will jointly decide whether to enter the extended study part. Extended research: It is planned to enroll about 43 subjects, and the initial dosage of Jaktinib Hydrochloride Tablets is planned to be 100mg Bid. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04217993
Study type Interventional
Source Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact
Status Completed
Phase Phase 2
Start date January 7, 2020
Completion date August 3, 2022

See also
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Recruiting NCT03662126 - KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment Phase 2/Phase 3
Terminated NCT03935555 - Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib Phase 1
Recruiting NCT04878003 - Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis Phase 2
Available NCT04745637 - Managed Access Programs for INC424, Ruxolitinib