Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks required prior to and during screening
Greater than or equal to (\>=) 50 percent (%) and less than or equal to (\<=) 100% of predicted forced vital capacity (FVC) at screening
Stable baseline lung function as evidenced by a difference of less than (\<) 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to enrollment
\>=30% and \<=90% of predicted diffusion capacity of the lung for carbon monoxide at screening
Agree to use protocol defined methods of contraception
Male participants must agree not to donate semen during the study and for at least 2 months (or as per local requirements) after the last dose of vismodegib
Agree not to donate blood or blood products during the study and for at least 9 months (or as per local requirements) after the last dose of study treatment
You may not be if
Prior treatment with vismodegib or any Hh-pathway inhibitor
Evidence of other known causes of interstitial lung disease
Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
Lung transplant expected within 6 months of screening
Evidence of clinically significant lung disease other than IPF
Post-bronchodilator forced expiratory volume in 1 second/FVC ratio \<0.7 at screening
Any clinically significant medical disease (other than IPF) that is associated with an expected survival of \<6 months, likely to require a change in therapy during the study
Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction \<35%
Known current malignancy or current evaluation for a potential malignancy
Known immunodeficiency, including, but not limited to, human immunodeficiency virus infection
Evidence of acute or chronic hepatitis or known liver cirrhosis
Creatinine clearance \<=30 milliliter per minute, calculated using the Cockcroft-Gault formula
