A Phase One-B (1B) Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Valganciclovir
Valganciclovir 450 mg, 2 pills by mouth one time per day x 12 weeks
干预措施: Valganciclovir (Drug)
Placebo
Placebo, 2 pills by mouth one time per day x 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events
时间窗: 12 weeks
Proportion of study subjects who discontinue study drug due to adverse events
次要结局
- Adverse Events - Number(12 weeks)
- Serious Adverse Events(12 weeks)
- Total # Adverse Events(Randomization to 16 weeks)
研究者
Jonathan Kropski
Assistant Professor of Medicine
Vanderbilt University