Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK44459.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis (IPF). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label Extension Trial of the Long-term Safety and Efficacy of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Overview
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.
Interventions
- Drug HSK44459
HSK44459
Primary outcome measures
- The incidence and severity of adverse events during the study period [Time frame: Up to 52 weeks]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07019090 · HSK44459-204