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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01254409
Date of registration: 03/12/2010
Prospective Registration: Yes
Primary sponsor: Hoffmann-La Roche
Public title: A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) PRM151F-12GL
Scientific title: A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis
Date of first enrolment: January 2011
Target sample size: 21
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01254409
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 1
Countries of recruitment
Netherlands United States
Contacts
Name:     John Getsy, DMD, DO
Address: 
Telephone:
Email:
Affiliation:  Hoffmann-La Roche
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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).



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis
Intervention(s)
Biological: PRM-151
Other: Placebo
Primary Outcome(s)
Safety and Tolerability [Time Frame: From first dose on Day 1 through Day 57]
Secondary Outcome(s)
6MWT (6 Minute Walk Test) Distance Walked Change From Baseline [Time Frame: Screening (between Day -35 and Day 1) and Day 57]
AUC48 [Time Frame: Day 15]
Cmax [Time Frame: Day 15]
DLCO (%) (Diffusing Capacity of Carbon Monoxide) Change From Baseline [Time Frame: Day 1 (Baseline) and Day 57]
FEV1 (Forced Expiratory Volume 1sec )(%) Change From Baseline [Time Frame: Day 1 (Baseline) and Day 57]
FVC (Forced Vital Capacity) % Predicted Change From Baseline [Time Frame: Day 1 (Baseline) and Day 57]
FVC (Forced Vital Capacity) Change From Baseline to Day 57 [Time Frame: Change from Day 1 (Baseline) to Day 57]
SGRQ (St. George's Respiratory Questionnaire) Total Score Change From Baseline [Time Frame: Day 1 (Baseline) and Day 57]
Terminal Elimination Half Life [Time Frame: Day 15]
Tmax [Time Frame: Day 15]
Total Body Clearance [Time Frame: Day 15]
Vss [Time Frame: Day 15]
Secondary ID(s)
PRM151F-12GL
WA42403
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 02/11/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01254409
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