Health TrialsbyHealthPanel

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF

ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSunshine Lake Pharma Co., Ltd.

About this trial

A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this clinical study and sign the informed consent form before the study begins;

When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted;

Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading;

The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;

Disqualifiers

The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.

Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.

Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.

Within one month before randomization, any active infection requiring systemic treatment (such as oral or intravenous administration) in the form of activity (including bacterial, viral, parasitic or fungal infections).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEC585

    Drug

    HEC585 tablet, taken once daily

  • Placebo

    Drug

    HEC585 Simulation Board, taken once daily

  • Pirfenidone

    Drug

    Pirfenidone, taken three times a day

Treatment groups

472 Participants
are divided into 3 treatment groups
Group A: HEC585Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: pirfenidoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in FVC from baseline at 52 weeks (mL)

Time frame
52week

Secondary outcomes

1

The interval (in days) from the start of the study until the first occurrence of any of the following clinical events (whichever occurs first) within 52 weeks

Time frame
52week
2

The percentage of FVC relative to the predicted value (%FVC) compared to the baseline value changes

Time frame
52week
3

The percentage of DLco(Hb-correction) relative to the expected value [%DLco(Hb-correction)] and the change from the baseline value

Time frame
52week
4

The total walking distance of 6MWT（six minutes walk ）test compared to the baseline value

The longer the 6MWT distance is, the better the patient's disease condition is.

Time frame
52week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunshine Lake Pharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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