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|
- - Subjects voluntarily sign the informed consent form (ICF); - Age ≥ 18 years, either male or female; - Subjects diagnosed with a PMF according to World Health Organiztion (WHO) criteria (2016 Edition), or patients diagnosed with a Post-PV-MF or Post-EF-MF according to International Working Group for Myeloproliferative Neoplasms Research and Treatment (2007 IWG-MRT) criteria; - Subjects with intermediate-2 or high-risk myelofibrosis, or Intermediate-1 myelofibrosis with symptoms according to the Dynamic International Prognostic System (DIPSS) scoring system; - Subjects are relapsed/refractory to Ruxolitinib: 1.
- - Subject has a measurable splenomegaly: spleen volume of ≥ 450 cm3 by MRI/CT and ≥ 5 cm below left costal margin by palpation spleen measuring; - Expected life expectancy is greater than 24 weeks; - Eastern Cooperative Oncology Group (ECOG) performance Score 0-2; - Laboratory examination within 7 days before the randomization, fulfilling the following criteria: Neutrophil count ≥ 0.75 x 109/L, platelet count ≥ 75 x 109/L; Peripheral blood blasts ≤ 10%; ALT and AST≤ 3 ULN, DBIL ≤ 2.0 ULN; Serum creatinine ≤ 2.0 ULN.
- - Subjects who have been previously exposed to Janus kinase (JAK) inhibitors other than Ruxolitinib for a total of> 2 weeks; - Subjects who have taken Ruxolitinib or other JAK inhibitor within 1 week prior to screening; - Subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation, such as uncontrolled diabetes, uncontrolled hypertension after taking two or more hypotensive drugs or peripheral neuropathy; - Subjects with congestive heart failure (NCI-CTCAE V5.0) Class II or above, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening; - Subjects who have a history of chronic or recurrent respiratory diseases, such as: chronic obstructive pulmonary disease, recurrent lung infections, etc., or have a history of lung infections within 3 months before screening, or currently have upper respiratory tract infections that have not recovered; - Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening; - Subjects suffering from arrhythmia and requiring treatment, or QTcB > 480ms at screening; - Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening; - Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 6 months before screening; - Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC); - Female subjects who are pregnant, currently breastfeeding, planning to become pregnant; - Subjects who had experienced malignant tumors (except for adequately treated local basal cell or squamous cell carcinoma of the skin and cervical carcinoma in situ that have been cured) or in combination with other serious diseases within the past 5 years; - Subjects who have participated in another clinical trial of a new drug or medical instrument within 1 month before screening.
- - Subjects who have any other conditions that are not specified in the protocol but the investigator believes that they are not suitable for inclusion in this trial.
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, PhD|
|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.
All subjects will receive a minimum of 6 treatment cycles or 24 weeks (a 28-day treatment cycle is defined as one treatment cycle).
Experimental: Jaktinib 100mg Bid
Jaktinib twice daily for 6 consecutive 28-day cycles, orally, empty stomach
Drug: - Jaktinib Hydrochloride Tablets
Jaktinib 100mg Bid
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.