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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05060822
Other study ID # HEC585-P-03
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 30, 2021
Est. completion date May 11, 2025

Study information

Verified date April 2023
Source Sunshine Lake Pharma Co., Ltd.
Contact HuaPing Dai, MD
Phone 010-84206278
Email daihuaping@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HEC585
HEC585 Tablets,once daily
Pirfenidone
Pirfenidone,three times a day
Placebo
Placebo,once daily

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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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