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

NCT02871401 | Completed Phase 1 Results

• 1 other identifier: 160693
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF; Herpesvirus; Valganciclovir

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events

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

  12 weeks

Secondary Outcomes (3)

• Adverse Events - Number

  12 weeks

• Serious Adverse Events

  12 weeks

• Total # Adverse Events

  Randomization to 16 weeks

Other Outcomes (1)

• Change in Forced Vital Capacity (FVC)

  Baseline vs. 12 weeks, 1 year

Study Arms (2)

Valganciclovir

EXPERIMENTAL

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

Drug: Valganciclovir

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Also known as: Valcyte

Valganciclovir

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 33740394 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Herpes Simplex

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jonathan Kropski MD
• Organization: Vanderbilt University Medical Center

jon.kropski@vumc.org

615-322-3412

Study Officials

• Jonathan A Kropski, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: January 3, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 29, 2022
• Results First Posted: April 29, 2022

Record last verified: 2022-04

Locations

US (1)