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Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease

Study acronym: FIBROPOC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Study sites: 3 to 5v6
  2. Minor Study sites: 4 to 3
    • Eligibility criteria expanded, about 2 words
    v5
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to Aug 1, 2025
    • Site details revised at 4 of 4 sites
    v4
  4. Minor Start date: May 2025 to Jun 2025
    • Study description expanded, about 11 words
    v3
  5. Notable Start date: Jan 2025 to May 2025v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease. Researchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening. Participants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.
Trial Details
NCT Number NCT06714123
Lead Sponsor Vejle Hospital
Collaborators: Odense Patient Data Explorative Network
Conditions
(from sponsor)
Pulmonary Fibrosis, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
Related terms Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial, Pulmonary Fibrosis
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov