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Jaktinib for the Treatment of Ruxolitinib Intolerance of Myelofibrosis

NCT04217993 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-04-20

No results posted yet for this study

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.

Conditions

  • Primary Myelofibrosis (PMF)
  • Post-polycythemia Vera Myelofibrosis(Post-PV MF)
  • Post-essential Thrombocythemia Myelofibrosis(Post-ET MF)

Interventions

DRUG

Jaktinib hydrochloride tablets

Jaktinib hydrochloride tablets 100mg twice dose group，Jaktinib hydrochloride tablets 150mg qd dose group, Jaktinib hydrochloride tablets 200mg qd dose group and Jaktinib hydrochloride tablets 100mg 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2022-08-03
Completion
2022-08-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04217993 on ClinicalTrials.gov