Long-term Safety and Efficacy Study of HSK44459 Tablets i... | NCT07019090

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

NCT07019090

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jun 13, 2025Actual

Enrollment

120Estimated

Phase

Phase 2

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

HSK44459

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2025Estimated

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Jan 19, 2027Estimated

First Submitted Date

Jun 5, 2025

First Submission Date that Met QC Criteria

Jun 5, 2025

First Posted Date

Jun 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Label	Type	Description	Intervention Names
HSK44459	Experimental		Drug: HSK44459

Name	Type	Description	Arm Group Labels	Other Names
HSK44459	Drug	HSK44459	HSK44459

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence and severity of adverse events during the study period		Up to 52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Cao yong	Contact	18036618841		caoyong@haisco.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D011658	Pulmonary Fibrosis
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided