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

NCT07019090 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK44459-204
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events during the study period

  Up to 52 weeks

Study Arms (1)

HSK44459

EXPERIMENTAL

Drug: HSK44459

Interventions

HSK44459 DRUG

HSK44459

HSK44459

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Cao yong

CONTACT

18036618841; caoyong@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 19, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share