Phase 1
N=31
A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02871401 ↗Enrolled (actual)
31
Serious AEs
9.7%
Results posted
Apr 2022
Primary outcome: Primary: Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events — 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Valganciclovir (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events |
1; 0 | — |
| SECONDARY Adverse Events - Number |
14; 4; 3; 1; 1; 3 | — |
| SECONDARY Serious Adverse Events |
2; 1 | — |
| SECONDARY Total # Adverse Events |
33; 13 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age >21 and 40% by HRCT)
- Active tobacco use (cigarette or cigar smoking)
- Resting oxygen saturation (SpO2) on room air 2 x upper limit of normal (ULN)
- hematology outside of specified limits: white blood cells (WBCs) 59%; platelets 2 x ULN
- Aspartate (AST) or alanine aminotransferases (ALT)/ serum glutamic-oxaloacetic; transaminase (SGOT), or serum glutamic pyruvic transaminase (SGPT) > 2.0 x ULN
- alkaline phosphatase > 3 x ULN
- albumin < 3.0 mg/dL at screening
- known hypersensitivity to study medication
- any condition that, in the judgment of the PI, might cause participation in this study to be detrimental to the subject or that the PI deems makes the subject a poor candidate
- any therapy with immunosuppressants such as prednisone, azathioprine, or mycophenolate currently or anticipated to be needed during the study period (subjects on these drugs prior to the study will require a 30-day washout period before randomization)
- participation in another IPF clinical treatment trial during the study period (if completing another IPF clinical treatment trial, then a 30-day washout period is required before randomization)
- requirement for chronic suppressive therapy with valacyclovir for recurrent herpes virus infection
- History of myelodysplasia, aplastic anemia, refractory anemia, or multiple myeloma.
Data sourced from ClinicalTrials.gov (NCT02871401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.