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Clinical Trial Finder

Search Results

Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis

Study Purpose

This study is to determine the efficacy of Jaktinib versus Hydroxycarbamid in participants with Intermediate-2 or High-risk myelofibrosis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥ 18 years old,either male or female; - Subjects diagnosed with a PMF according to World Health Organiztion 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 criteria; - High risk or intermediate-2 risk as defined by the Dynamic International Prognostic Scoring System (DIPSS) for Primary Myelofibrosis; - Subjects have no plan for stem cell transplantation in the near future; - Life expectancy of > 24 weeks; - ECOG performance status of 0-1; - Palpable splenomegaly at least 5 cm below left costal margin; - Peripheral blood blast count ≤ 10%; - Subjects who have not yet received treatment with a JAK inhibitor, or Subjects who have been treated with JAK inhibitors for ≤10 days; - Subjects have not received growth factor, thrombopoietin mimetics or platelet transfusion(s) within 2 weeks before the randomization; ANC≥ 1.0×10^9/L, platelet count ≥ 100×10^9/L within 2 days before the randomization; - Normal functions in major organs within 7 days before the randomization, fulfilling the following criteria: ALT and AST ≤ 2.5×ULN; DBIL and TBIL ≤ 2.0×ULN; serum creatinine ≤ 1.5×ULN; - If the subject is receiving any anti-myelofibrosis treatment (except for JAK inhibitors and hydroxyurea) at screening, the dosing regimen must remain unchanged for at least 2 weeks before screening.
If the investigator judges that there is no need to continue to use, stop the use of thalidomide, androgens and prednisone> 10 mg during screening. The drugs used to improve anemia should be stopped for at least 6 half-lives or 2 weeks before randomization(whichever is the longer);
  • - If the subject is receiving Hydroxycarbamide treatment at screening, the drug must be discontinued ≥ 2 weeks before the randomization; - Meet the requirements of the ethics committee and willing to sign the informed consent form; - Ability to comply with trial and follow-up procedures.

Exclusion Criteria:

  • - 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, peripheral neuropathy; - Subjects with congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident, or pulmonary embolism within 24 weeks prior to screening; - Subjects who have not fully recovered from surgical operation within 4 weeks prior to screening; - Subjects suffering from arrhythmia and requiring treatment at screening; - Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening; - Chest X-rays suggest an active lung infection at screening; - Subjects who had active tuberculosis infection within 48 weeks before screening;γ-Interferon release test suggests latent tuberculosis infection at screening; - Subjects who had undergone splenectomy, or received radiotherapy to the spleen within 48 weeks before screening; - Subjects with known human immunodeficiency virus (HIV), known active infectious Hepatitis B (HepB), and/or known active infectious Hepatitis C (HepC); - Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening; - Female subjects who are pregnant, currently breastfeeding, planning to become pregnant;Subjects who are unable to adopt effective contraceptive methods during the study; Male subjects who did not use condoms during the dosing period and within 2 days after the last dose.
  • - Subjects who had experienced malignant tumors within the past 5 years (except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ that have been cured); - Subjects who are unsuitable to the trial in combination with other serious diseases, as identified by the investigator; - Subjects with suspected allergies to Jaktinib or its excipient; - Subjects who have participated in another clinical trial of a new drug or medical instrument within 12 weeks before screening.

Trial Details

Trial ID:

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.

NCT04617028
Phase

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.

Phase 3
Lead Sponsor

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
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis
Arms & Interventions

Arms

Experimental: Jaktinib

Participants will receive Jaktinib plus placebo to match Hydroxycarbamide.

Active Comparator: Hydroxycarbamide

Participants will receive Hydroxycarbamide plus placebo to match Jaktinib.

Interventions

Drug: - Jaktinib

Jaktinib Hydrochloride Tablets administered orally twice daily

Drug: - Placebo to match Hydroxycarbamide

Placebo to match Hydroxycarbamide Tablets administered orally twice daily

Drug: - Hydroxycarbamide Tablets

Hydroxycarbamide Tablets administered orally twice daily

Drug: - Placebo to match Jaktinib

Placebo to match Jaktinib Tablets administered orally twice daily

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.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, 310003

Site Contact

Jie Jin, PhD

jiej0503@163.com

13505716779

Nearest Location

Site Contact

Jie Jin, PhD

jiej0503@163.com

13505716779

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