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NCT Number: NCT07019090

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HSK44459

Drug

HSK44459

Primary outcomes

  1. The incidence and severity of adverse events during the study period

    Time frame: Up to 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Cao yong

CONTACT

[email protected]

18036618841

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

An Open-label Extension Trial of the Long-term Safety and Efficacy of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Acronym: IPF

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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