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NCT02871401 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT02871401 is a Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 31 participants.
The verdict
NCT02871401, a Phase 1 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The investigators will conduct a single-center, prospective, randomized, placebo-controlled, double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability will be determined by type, frequency and duration of adverse events (AEs) and serious adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon completion of treatment (12 weeks). Subjects will then be followed up at routine clinic visits at 6, 9 and 12 months for data collection.
Interventions
- DRUG Placebo
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02871401
The ClinicalTrials.gov registry entry for NCT02871401 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02871401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02871401 about?
NCT02871401 is a clinical study titled "A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)". The investigators will conduct a single-center, prospective, randomized, placebo-controlled, double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current or past Epstein-Barr V...
What is the current status of trial NCT02871401?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2018-01-03. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT02871401?
The interventions under investigation include: Placebo (DRUG), Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT02871401?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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