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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2027-01-19

Brief Summary

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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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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HSK44459

Group Type EXPERIMENTAL

HSK44459

Intervention Type DRUG

HSK44459

Interventions

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HSK44459

Intervention Type DRUG

Eligibility Criteria

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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

1. Patient will plan to undergo lung transplantation.
2. 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.
3. History of malignancy within 5 years prior to screening.
4. History of depression or anxiety disorder.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No