NCT07019090Not yet recruitingPhase 2
Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
An Open-label Extension Trial of the Long-term Safety and Efficacy of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 27 Jun 2025
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07019090
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 27 Jun 2025 to the primary completion date, 31 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of malignancy within 5 years prior to screening.
- History of depression or anxiety disorder.
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.