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

Launched by HAISCO PHARMACEUTICAL GROUP CO., LTD. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and effectiveness of a medication called HSK44459 in patients with idiopathic pulmonary fibrosis (IPF), a lung disease that makes it hard to breathe. To participate, patients must have previously taken HSK44459 in another study and completed their treatment without stopping early. The goal is to see how well these patients can tolerate taking HSK44459 over a longer period.

To be eligible for this study, patients should not be planning to get a lung transplant and should not have certain health issues, such as a very low body weight or a history of significant weight loss during earlier trials. They also should not have had any major cancers recently or suffer from severe depression or anxiety. If selected, participants can expect to continue their treatment with HSK44459 while the researchers monitor their health and any side effects. This trial is not yet recruiting, so it's an opportunity for patients who have already been involved in earlier studies to continue exploring this treatment option.

Gender

ALL

Eligibility criteria

• 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.