Status:
COMPLETED
Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, randomized, double-blinded, and placebo-controlled phase II study to evaluate the efficacy and safety of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonar...
Eligibility Criteria
Inclusion
- Written informed consent signed;at least 50 years of age;no gender limitation.
- Diagnosed idiopathic pulmonary fibrosis(see 2018.9 guidance that AST and ERS and JRS and ALAT publish );
- FVC%≥45% normal predicted value;
- DLCO≥30% normal predicted value；
- FEV1 / FVC ≥0.7
Exclusion
- A plan of lung transplant after into group for one year.
- In addition of IPF,Other causes cause interstitial lung disease in patients；
- Patients with bleeding tendency (INR \> 2, PT or APTT \> 1.5 times normal) or cerebral hemorrhage in the past 1 year;
- Have used anticoagulant drugs within 1 month（Except for low molecular weight heparin）;
- An alcoholic or drug abuser;
- Expected survival ≤ one year;
- Patients who plan to undergo a operation within study period, such as major operations on chest and abdomen;
- Previous use of a JAK inhibitor for more than 10 days or treatment failure;
- Suspected allergic to Jaktinib Dihydrochloride Monohydrate , similar drugs (Fedratinib,Ruxolitinib)or their excipients;
- Patients with malignant tumors in the previous 5 years;
- Patients with other serious diseases that investigators believe may affect patient safety or compliance;
- Any significant clinical or laboratory abnormalities that the investigator considers to affect safety assessment, such as: a. uncontrolled diabetes (13.9 tendency \> / 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 v5.0 standard grade 2 or above)；
- Patients hospitalized for deterioration or acute exacerbation of IPF within 1 month prior to screening;
- patients who had not fully recovered from surgery within 1 month prior to screening;
- Participate in clinical trials of other new drugs or medical devices within 3 months before screening;
- Prednisone \> 15mg/ day or equivalent within 1 month prior to screening;
- Those who had used pirfenidone, Nintedanib, azathioprine, cyclophosphamide, cyclosporine A or other immunosuppressive drugs within 1 month prior to screening;
- A history of congestive heart failure, uncontrolled or unstable angina or myocardial infarction, cerebrovascular accident or pulmonary embolism occurred within 6 month prior to screening;
- Patients with active TB in the 12 months prior to screening;
- Screening patients with arrhythmia requiring treatment, or with QTcB \>480ms;
- At the time of screening, there was evidence of severe impairment of organ function : including ALT and AST \> 2.5uln;DBIL and TBIL \> 2.0 ULN;Serum creatinine \> was 1.5 ULN.
- Evidence of active and uncontrolled viral infections such as HIV, HBV (HBsAg positive, hbv-dna positive or ≥10000 copies /ml), HCV (anti-hcv antibody or hcv-rna positive), or bacterial, viral, parasitic or fungal infections requiring treatment with any clinical symptoms;
- patients with a history of progressive multifocal leukoencephalopathy in Screening ;
- Patients with epilepsy or using antipsychotics(Sleep medicine,for diazepam expect) for treatment of mental illness( schizophrenia,depressed,mania,anxiety,and so on) at the time of screening;
- Women who are planning to become pregnant or who are pregnant or breast-feeding and who are unable to use effective contraception throughout the trial period;Male patients who did not use condoms during administration and within 1 month after the last dose;
- Subjects who cannot be treated and followed up according to the protocol;
- Any subject whom the investigator considers inappropriate for this clinical study.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2022
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04312594
Start Date
September 8 2020
End Date
June 9 2022
Last Update
December 12 2024
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730