Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.
NCT03886415 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2022-11-29
Summary
This was an open-label, multi-center, randomized phase 2 study. This is a two-stage design.In the first stage, two dose groups were set up, the 100 mg bid dose group and the 200 mg qd dose group, which were randomized at 1:1, with 50 subjects in each group, and a total of 100 cases in the two groups. In the second stage, approximately 36 subjects were added to the randomized group.
Conditions
Interventions
- DRUG
-
Jaktinib hydrochloride tablets
Jaktinib hydrochloride tablets 100mg bid dose group and Jaktinib hydrochloride tablets 200mg qd dose group
Sponsors & Collaborators
-
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
lead INDUSTRY
Principal Investigators
-
Jie Jin, MD · The First Affiliated Hospital of Medical School of Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-08
- Primary Completion
- 2021-02-02
- Completion
- 2021-02-02
Countries
- China
Study Locations
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