NCT03886415

Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.

A Phase 2,Multi-center, Open-label Study Evaluating Safety and Efficacy of Jaktinib Hydrochloride Tablets in Intermediate-risk and High-risk Myelofibrosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

According to the results of the interim analysis of the ZGJAK002 of Jaktinib, a comprehensive evaluation of the benefits and risks of subjects in the 100mg bid and 200mg qd groups, the investigator and the sponsor decided to expand the enrollment of approximately 36 subjects taking 100mg bid.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	Jaktinib hydrochloride tablets	Jaktinib hydrochloride tablets 100mg bid dose group and Jaktinib hydrochloride tablets 200mg qd dose group

Timeline

• Start date: 2019-01-08
• Primary completion: 2021-02-02
• Completion: 2021-02-02
• First posted: 2019-03-22
• Last updated: 2022-11-29

Locations

1 site across 1 country: China