Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion criteria:1、18 years age or older ,male or female; 2、Patients diagnosed with Primary Myelofibrosis according to WHO standard (2016 version), or patients diagnosed with Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis according to International Working Group Myeloproliferative Neoplasms Research and Treatment(IWG-MRT) standard. Both Janus Kinase 2(JAK2)mutation and JAK2 wild can be enrolled； 3、According to Dynamic International Prognostic Scoring System plus(DIPSS-plus) risk grouping criteria, patients with medium-risk-2 or high-risk myelofibrosis were assessed,Patients with grade 1 medium-risk myelofibrosis with hepatosplenomegaly and no response to existing treatment and requiring treatment can also be enrolled; 4、Subjects did not have a recent stem cell transplant program; 5、a life expectancy > 24 weeks; 6、Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2； 7、Splenomegaly: palpation of the splenic margin to or above the subcostal at least 5 cm； 8、Peripheral blood protocells ≤10%； 9、Patients who have not previously been treated with JAK inhibitors； 10、Absolute neutrophil count（ANC） ≥1000/uL, platelet count ≥75 × 109/L without growth factor, platelet production factor or platelet infusion.Subjects did not receive growth factor infusion within 2 weeks before randomization; 11、Seven days before randomization, the main organs were functioning normally, which met the following criteria： alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)； direct bilirubin（DBIL）and total bilirubin (TBIL)≤1.5×upper limit of normal (ULN）；serum creatinine ≤2.5×upper limit of normal (ULN)，calculated creatinine clearance（CrCl）≥50mL/min； 12、 Voluntarily sign informed consent in accordance with the requirements of the ethics committee; 13、Ability to follow study and follow-up procedures；
Exclusion Criteria:1. Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (> 250 mg/dL, or 13.9 mmol > / L), b. had high blood pressure and antihypertensive drug treatment under two or unable to descend to the ranges (systolic blood pressure < 160 mmHg, diastolic pressure < 100 mmHg), c. peripheral neuropathy (NCI
- - CTC AE v4.03 standard grade 2 or above), d.
- - CTC AE v4.03 standard grade 2 or above); 2.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Suzhou Zelgen Biopharmaceuticals Co.,Ltd|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jie Jin, MD|
|Principal Investigator Affiliation||The First Affiliated Hospital of Medical School of Zhejiang University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Experimental: Jaktinib hydrochloride tablets 1
This is the dose group was given once a day. Jaktinib hydrochloride tablets 1 200mg qd dose group
Experimental: Jaktinib hydrochloride tablets 2
This is the dose group was given twice a day. Jaktinib hydrochloride tablets 2 100mg bid dose group
Drug: - Jaktinib hydrochloride tablets
Jaktinib hydrochloride tablets 100mg bid dose group and Jaktinib hydrochloride tablets 200mg qd dose group
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.