NCT07019090Not yet recruitingPhase 2
An Open-label Extension Trial of the Long-term Safety and Efficacy of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Haisco Pharmaceutical Group Co., Ltd.0 sites120 target enrollmentStarted: June 27, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- The incidence and severity of adverse events during the study period
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patient will plan to undergo lung transplantation.
- •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.
- •History of malignancy within 5 years prior to screening.
- •History of depression or anxiety disorder.
Arms & Interventions
HSK44459
Experimental
Intervention: HSK44459 (Drug)
Outcomes
Primary Outcomes
The incidence and severity of adverse events during the study period
Time Frame: Up to 52 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
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