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OpenTrials
Completed

NCT Number: NCT06485635

Real-life-persistence to Antifibrotic Treatments

This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.

Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinityx

Boulogne-Billancourt, 92100, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.

Exclusion criteria

No exclusion criteria will be applied.

Treatment and study plan

Nintedanib

Drug

Nintedanib

pirfenidone

Drug

Pirfenidone

Primary outcomes

  1. Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation)

    Time frame: up to 30 months

Secondary outcomes

  1. AF prevalence in French population

    Time frame: up to 5 years

  2. AF incidence in French population

    Time frame: up to 4 years

  3. Number of AF treated patients split by indication

    Time frame: up to 2 years

    Indications:

    • Idiopathic Pulmonary Fibrosis (IPF)
    • Interstitial Lung Disease associated with Systemic Sclerosis (SSc-ILD)
    • Progressive Pulmonary Fibrosis (PPF)

  4. Number of patients adherent to AF treatment

    Time frame: up to 30 months

    In incident AF patients, percentage of days covered (PDC) will be calculated at different time point to measure the adherence to AF treatment for patients persistent to treatment at this time point.

    The PDC is the ratio dividing the number of days exposed by the number of days in the period evaluated.

    A PDC≥ 80% is considered as a good adherence to medication.

  5. Percentage of the target cumulative dose of treatment received by the patients

    Time frame: up to 30 months

  6. Influence of factors (yes/no) associated with persistence to AF treatments

    Time frame: up to 30 months

    For a pre-determined list of variables (as defined in the study protocol) in incident AF patients, a multivariate time-dependant Cox model will test several covariates to check if they are associated with persistence to AF treatment.

  7. Number of patients with switch from one AF treatment to the another with no treatment stop

    Time frame: up to 5 years

  8. Number of patients at site of follow-up (identified as 2 lung function tests performed in the center)

    Time frame: up to 5 years

  9. Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause)

    Time frame: up to5 years

  10. Event-free survival

    Time frame: up to 5 years

    Defined as the time from index date to

    • oxygenotherapy onset
    • hospitalisation for respiratory exacerbations
    • hospitalisation for other respiratory diseases
    • ath from any cause

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Acronym: REPEAT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Apr 15, 2026

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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