Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Haisco Pharmaceutical Group

Status and phase: Begins enrollment this month; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Treatments: Drug: HSK44459

Study type: Interventional

Funder types: Industry

Identifiers

NCT07019090

HSK44459-204

Details and patient eligibility

About

This study is open to people with idiopathic pulmonary fibrosis (IPF) . They can only take part if they have completed treatment in a previous study with a medicine called HSK44459.

The primary object of this study is to find out how well people with idiopathic pulmonary fibrosis (IPF) tolerate long- term treatment with HSK44459.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1.IPF patients who completed the last dose treatment of HSK44459 in previous trials without prematurely discontinuing treatment permanently according to protocol , and have been evaluated by the researchers to have greater benefits than risks, and may benefit from continued treatment with HSK44459

Exclusion criteria

1. Patient will plan to undergo lung transplantation.
2. Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an unexplained and clinically significant (>10%) weight loss during the previous trials.
3. History of malignancy within 5 years prior to screening.
4. History of depression or anxiety disorder.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

HSK44459

Experimental group

Treatment:

Drug: HSK44459