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Completed

NCT Number: NCT02871401

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 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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age >21 and <80 years
  • ability to provided informed consent
  • diagnosis of probable or definite IPF according to American Thoracic Society (ATS) criteria
  • tolerance of full-dose (2403 mg/day) pirfenidone
  • Positive serology for EBV or CMV

Exclusion criteria

  • FVC < 40% predicted
  • Diffusing capacity for carbon monoxide (DLCO) < 35% predicted (Crapo)
  • Forced expiratory volume (FEV)1/FVC <0.7
  • Significant centrilobular emphysema (>40% by HRCT)
  • Active tobacco use (cigarette or cigar smoking)
  • Resting oxygen saturation (SpO2) on room air <89%
  • Listed for lung transplantation defined as being assigned a lung allocation score
  • environmental exposure (occupational, environmental, drug, etc.) felt by the principal investigator (PI) to be the etiology of the interstitial disease
  • diagnosis of collagen-vascular conditions (according to the published American College of Rheumatology criteria)
  • history of unstable or deteriorating cardiac disease
  • acute coronary syndrome, coronary artery bypass, or angioplasty within 3 months of screening
  • uncontrolled arrhythmia
  • uncontrolled hypertension
  • known HIV or hepatitis C
  • known cirrhosis or chronic active hepatitis
  • active substance or alcohol abuse
  • pregnancy or lactation
  • Women of childbearing potential who are not using a medically approved means of contraception. Subjects will be considered of childbearing potential if they are not surgically sterile or have not been postmenopausal for at least 2 years [any subject who is postmenopausal for < 2 years will be required to have a follicle-stimulating hormone (FSH) level to assess her potential to become pregnant
  • clinically relevant lab abnormalities (obtained within 30 days before enrollment), including:
  • creatinine > 2 x upper limit of normal (ULN)
  • hematology outside of specified limits: white blood cells (WBCs) < 3,500/mm3; hematocrit < 25% or > 59%; platelets < 100,000/mm3;
  • total bilirubin > 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.

Treatment and study plan

Valganciclovir

Drug

Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.

Other names: Valcyte

Placebo

Drug

Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.

Primary outcomes

  1. Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events

    Time frame: 12 weeks

    Proportion of study subjects who discontinue study drug due to adverse events

Secondary outcomes

  1. Adverse Events - Number

    Time frame: 12 weeks

    Number of subjects with each reported adverse event

  2. Serious Adverse Events

    Time frame: 12 weeks

    Number of subjects with each serious adverse event

  3. Total # Adverse Events

    Time frame: Randomization to 16 weeks

    Total number of adverse events

Other outcomes

  1. Change in Forced Vital Capacity (FVC)

    Time frame: Baseline vs. 12 weeks, 1 year

    Change in FVC percent predicted compared to baseline

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 18, 2016
Registry last updated
Apr 29, 2022

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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