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A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Valganciclovir
Placebo
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, Herpesvirus, Valganciclovir

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. FVC < 40% predicted
  2. Diffusing capacity for carbon monoxide (DLCO) < 35% predicted (Crapo)
  3. Forced expiratory volume (FEV)1/FVC <0.7
  4. Significant centrilobular emphysema (>40% by HRCT)
  5. Active tobacco use (cigarette or cigar smoking)
  6. Resting oxygen saturation (SpO2) on room air <89%
  7. Listed for lung transplantation defined as being assigned a lung allocation score
  8. environmental exposure (occupational, environmental, drug, etc.) felt by the principal investigator (PI) to be the etiology of the interstitial disease
  9. diagnosis of collagen-vascular conditions (according to the published American College of Rheumatology criteria)
  10. history of unstable or deteriorating cardiac disease
  11. acute coronary syndrome, coronary artery bypass, or angioplasty within 3 months of screening
  12. uncontrolled arrhythmia
  13. uncontrolled hypertension
  14. known HIV or hepatitis C
  15. known cirrhosis or chronic active hepatitis
  16. active substance or alcohol abuse
  17. pregnancy or lactation
  18. 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

  19. clinically relevant lab abnormalities (obtained within 30 days before enrollment), including:

    1. creatinine > 2 x upper limit of normal (ULN)
    2. hematology outside of specified limits: white blood cells (WBCs) < 3,500/mm3; hematocrit < 25% or > 59%; platelets < 100,000/mm3;
    3. total bilirubin > 2 x ULN
    4. Aspartate (AST) or alanine aminotransferases (ALT)/ serum glutamic-oxaloacetic; transaminase (SGOT), or serum glutamic pyruvic transaminase (SGPT) > 2.0 x ULN
    5. alkaline phosphatase > 3 x ULN
    6. albumin < 3.0 mg/dL at screening
  20. known hypersensitivity to study medication
  21. 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
  22. 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)
  23. 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)
  24. requirement for chronic suppressive therapy with valacyclovir for recurrent herpes virus infection
  25. History of myelodysplasia, aplastic anemia, refractory anemia, or multiple myeloma.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valganciclovir

Placebo

Arm Description

Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks

Placebo, 2 pills by mouth one time per day x 12 weeks

Outcomes

Primary Outcome Measures

Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
Proportion of study subjects who discontinue study drug due to adverse events

Secondary Outcome Measures

Adverse Events - Number
Number of subjects with each reported adverse event
Serious Adverse Events
Number of subjects with each serious adverse event
Total # Adverse Events
Total number of adverse events

Full Information

First Posted
August 15, 2016
Last Updated
April 25, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02871401
Brief Title
A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Official Title
A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
IPF, Herpesvirus, Valganciclovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valganciclovir
Arm Type
Experimental
Arm Description
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 pills by mouth one time per day x 12 weeks
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
Valcyte
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
Description
Proportion of study subjects who discontinue study drug due to adverse events
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adverse Events - Number
Description
Number of subjects with each reported adverse event
Time Frame
12 weeks
Title
Serious Adverse Events
Description
Number of subjects with each serious adverse event
Time Frame
12 weeks
Title
Total # Adverse Events
Description
Total number of adverse events
Time Frame
Randomization to 16 weeks
Other Pre-specified Outcome Measures:
Title
Change in Forced Vital Capacity (FVC)
Description
Change in FVC percent predicted compared to baseline
Time Frame
Baseline vs. 12 weeks, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan A Kropski, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33740394
Citation
Blackwell TS, Hewlett JC, Mason WR, Martin S, Del Greco J, Ding G, Wu P, Lancaster LH, Loyd JE, Dudenhofer RB, Salisbury ML, Kropski JA. A Phase I Randomized, Controlled, Clinical Trial of Valganciclovir in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Aug;18(8):1291-1297. doi: 10.1513/AnnalsATS.202102-108OC.
Results Reference
derived

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A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)

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