Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bridge Biotherapeutics, Inc.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male patients who have completed family planning or female patient, aged 40 years or older
Diagnosis of IPF in accordance with American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines for diagnosis in effect at the time of screening
Chest high-resolution computed tomography (HRCT) performed according to ATS guidelines within 12 months prior to screening and according to minimum requirements for IPF diagnosis by central review based on HRCT and lung biopsy. If no historical acceptable HRCT is available prior to screening, an HRCT can be performed during screening. In both cases, a central reading of the HRCT has to be done as well as a review of lung biopsy slides, if available and potentially supportive for diagnosis.
Able to walk at least 150 meters during the 6MWT at screening
Resting oxygen saturation of ≥89% using a maximum of 6 L/min of supplemental oxygen at sea level, and up to 8 L/min at altitude during screening
FVC ≥45% predicted of normal
Ratio of forced expiratory volume in the first second (FEV1) to FVC ≥0.7
Diffusing capacity for the DLCO corrected for hemoglobin ≥30% predicted of normal
Absence of IPF improvement in the past year, as determined by the investigator
Patients receiving either pirfenidone or nintedanib, should be on it for at least 3 months and with a stable dose in the 4 weeks prior to screening, OR taking neither pirfenidone
You may not be if
Unable to perform spirometry as per ATS
Evidence of IPF exacerbation within 3 months prior to and/or during screening
Evidence of emphysema extent greater than the extent of fibrosis
Current smoker (tobacco, e-cigarette)
History of lung transplant or lung volume reduction surgery
Current immunosuppressive condition
Estimated life expectancy of less than 12 months or 30 months in the opinion of the investigator
Congestive heart failure class III or IV according to New-York Heart Association classification
Pulmonary hypertension (PH) requiring PH specific therapy
Unstable cardiovascular, pulmonary or other disease within 6 months prior to screening or during the screening period
Use of other medications likely to interfere with study assessments
Any other current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the study or the evaluation of its results
Clareo Health | To Evaluate the Efficacy, Safety, and Tolerability of BBT-877 in Patients With IPF
