Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
A Phase II, Multi-center, Randomized, Placebo-controlled (Double-blind Design), Active Comparator-controlled (Open-label Design), Parallel-group, Dose-finding Study, to Evaluate the Efficacy and Safety of HEC585 Tablets in Patients With IPF
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
Status | Recruiting |
Enrollment | 270 |
Est. completion date | May 11, 2025 |
Est. primary completion date | May 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Volunteer to participate in this clinical study and sign the ICF before the study begins; - Aged 40-80 (including 40 and 80) ; - Female or male subjects with child-bearing potential who agree and promise to take effective contraceptive measures; - Diagnosed with IPF according to the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline for IPF Diagnosis (2018); - FEV1/FVC = 0.7; - FVC = 45% predicted; - DLCO corrected for Haemoglobin (Hb) = 30% predicted of normal; - In the opinion of the Investigator, subjects are willing and able to comply with the protocol requirements and attend the visit. Exclusion Criteria: - In the opinion of the Investigator, subjects underwent significant deterioration in IPF within one month before randomization; - Interstitial lung disease caused by other known causes; - Any bacterial, viral, parasitic or fungal infection that needs to be treated at screening; - Expected to receive lung transplantation during the study; - Expected survival is less than 6 months; - History of tumors within 5 years before screening (except for localized cancers such as basal cell carcinoma); - Moderate to severe hepatic insufficiency (Child-Pugh grade B or C, see Appendix 4); - History of unstable or worsening heart disease within 6 months before screening; - Cannot perform 6MWT or PFT; - Allergic to any component of HEC585 Tablets or pirfenidone tablets; - Participated in other clinical study and received the last dose within 3 months before screening; - Pregnant or breastfeeding; - History of smoking within 3 months before screening or are unwilling to quit smoking during the study; - Subjects often drink alcohol within 6 months before the screening (drink more than 21 units of alcohol a week), or refuse to reduce alcohol intake during the study; - History of drug abuse within 6 months before the screening; - Family or personal history of QT prolongation syndrome; - Any condition that, in the opinion of the investigator, would compromise the safety or compliance of the subject, or prevent the subject from completing the study. - TBil > 1.5 × ULN or AST or ALT > 2 × ULN; - CLcr < 50 mL/min; - Human immunodeficiency virus (HIV) antibody is positive; - Uncontrolled hepatitis B virus infection or hepatitis C virus infection; - QTcF > 480 ms. - Subjects have received any of the following treatments within 28 days before randomization: 1. Any cytotoxic drug or immunosuppressant 2. Therapeutic drugs for IPF, including but not limited to pirfenidone, nintedanib, prednisone at > 15 mg/d or other glucocorticoids of the equivalent dose, N-acetylcysteine at > 600 mg/d. 3. Moderate and strong inhibitor or strong inducer of CYP1A2. 4. Strong inducers or strong CYP3A4 inhibitors. |
Country | Name | City | State |
---|---|---|---|
China | China-Japan Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Sunshine Lake Pharma Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline to Week 24 in %FVC compared with placebo | change in %FVC, measured using Spirometer, from baseline to week 24 | 24 Weeks | |
Secondary | Change from Baseline to Week 24 in %FVC compared with Pirfenidone | change in %FVC, measured using Spirometer, from baseline to week 24 | 24 Weeks | |
Secondary | Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone | change in %FVC, measured using Spirometer, from baseline to week 12 | 12 Weeks | |
Secondary | Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10% | The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at W24 | 24 Weeks | |
Secondary | Time to first acute IPF exacerbation | 24 Weeks | ||
Secondary | All-cause mortality | 24 Weeks | ||
Secondary | IPF related mortality | 24 Weeks | ||
Secondary | Changes of 6MWT results | 12 Weeks, 24 Weeks | ||
Secondary | Changes of SGRQ scores | 12 Weeks, 24 Weeks | ||
Secondary | Changes of DLco (Hb correction) | 12 Weeks, 24 Weeks | ||
Secondary | Changes of resting SpO2 | 12 Weeks, 24 Weeks |
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