Status:
COMPLETED
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease with a histological picture of usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor. Chronic alveolar i...
Eligibility Criteria
Inclusion
- Men or women of non-childbearing potential aged 40 to 80 years at screening.
- Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution computerized tomography (HRCT) and pulmonary function tests.
Exclusion
- History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis, sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary fibrosis (IPF).
- History or presence of chronic pulmonary obstructive disease, severe pulmonary hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or interstitial lung diseases associated with environmental exposure medication or systemic disease.
- High resolution computerized tomography (HRCT) findings inconsistent with idiopathic pulmonary fibrosis(IPF).
Key Trial Info
Start Date :
March 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01254409
Start Date
March 29 2011
End Date
July 2 2012
Last Update
April 20 2022
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
3
Center for Human Drug Research
Leiden, Netherlands