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Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions

Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions - Surrogate Endpoints for Overall Survival in Idiopathic Pulmonary Fibrosis Trials with Medical Interventions

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000059730
Enrollment
Unknown
Registered
2025-11-10
Start date
2025-11-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic pulmonary fibrosis

Interventions

None listed

Sponsors

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Population: patients with idiopathic pulmonary fibrosis (IPF). Diagnostic certainty: possible, probable, or definite IPF will be treated collectively as IPF if permitted by the original study design. Comorbidities: no restriction; comorbid conditions are not grounds for exclusion. IPAF: included if diagnosed as IPF and without a confirmed diagnosis of any collagen vascular disease.

Exclusion criteria

Exclusion criteria: Studies that enroll patients with active or ongoing acute exacerbation at baseline. Studies primarily recruiting non-IPF interstitial lung diseases (e.g., confirmed connective tissue disease-associated ILD). Non-human, pediatric-only, or non-clinical studies that do not match the target patient population.

Design outcomes

Primary

MeasureTime frame
The weighted Pearson's correlation coefficient (r) between the hazard ratios for surrogate endpoints - exacerbation-based (HR_ex) and composite survival endpoints (HR_comp) - and the hazard ratio for overall survival (HR_OS).

Countries

Japan

Contacts

Public ContactNobuyuki Horita

Yokohama City University Hospital Department of Respiratory Medicine

horitano@yokohama-cu.ac.jp0457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026