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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01769196
Registration number
NCT01769196
Ethics application status
Date submitted
14/01/2013
Date registered
16/01/2013
Date last updated
30/05/2017
Titles & IDs
Public title
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
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Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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Secondary ID [1]
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2012-001571-36
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Secondary ID [2]
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GS-US-322-0207
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Universal Trial Number (UTN)
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Trial acronym
RAINIER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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0
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Condition category
Condition code
Respiratory
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0
0
0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
0
0
0
0
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Connective tissue diseases
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Simtuzumab
Treatment: Drugs - Simtuzumab placebo
Experimental: Simtuzumab - Participants will receive simtuzumab for up to 254 weeks.
Placebo comparator: Simtuzumab Placebo - Participants will receive simtuzumab placebo for up to 254 weeks.
Treatment: Drugs: Simtuzumab
125 mg/mL single-dose vials administered subcutaneously once a week
Treatment: Drugs: Simtuzumab placebo
Simtuzumab placebo single-dose vials administered subcutaneously once a week
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival
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Assessment method [1]
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Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (= 10% relative decrease in FVC and = 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
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Timepoint [1]
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Up to 148 weeks
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Primary outcome [2]
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0
PFS Among the Participants With sLOXL2 = 50th Percentile
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Assessment method [2]
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0
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Timepoint [2]
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Up to 148 weeks
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Primary outcome [3]
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0
PFS Among the Participants With sLOXL2 = 75th Percentile
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Assessment method [3]
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0
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Timepoint [3]
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Up to 148 weeks
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
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Timepoint [1]
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Up to 151 weeks
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Secondary outcome [2]
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0
Overall Survival Among the Participants With sLOXL2 = 50th Percentile
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Assessment method [2]
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0
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Timepoint [2]
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Up to 151 weeks
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Secondary outcome [3]
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0
Overall Survival Among the Participants With sLOXL2 = 75th Percentile
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Assessment method [3]
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0
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Timepoint [3]
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Up to 151 weeks
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Secondary outcome [4]
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Relative Change From Baseline in FVC % Predicted
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Assessment method [4]
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* FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.
* Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130
* The relative change was calculated as 100% \* ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
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Timepoint [4]
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Weeks 54, 106, and 130
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Secondary outcome [5]
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Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
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Assessment method [5]
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Timepoint [5]
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Up to 148 weeks
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Secondary outcome [6]
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Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
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Assessment method [6]
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Timepoint [6]
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Up to 148 weeks
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Secondary outcome [7]
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Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
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Assessment method [7]
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0
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Timepoint [7]
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Up to 148 weeks
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Secondary outcome [8]
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Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
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Assessment method [8]
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* Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.
* The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
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Timepoint [8]
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Weeks 58, 106, and 130
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Secondary outcome [9]
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Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
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Assessment method [9]
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* The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.
* The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
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Timepoint [9]
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Week 58, 106, and 130
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Eligibility
Key inclusion criteria
Key
* Male or female subjects from 45 to 85 years of age
* Definite IPF within 3 years prior to screening
* Be able to walk at least 50 meters
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Minimum age
45
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Significant diseases other than IPF
* Obstructive lung disease
* Aortic aneurysm greater than or equal to 3.5 cm in diameter
* Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.
* N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
* Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
* Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/02/2016
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Sample size
Target
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Accrual to date
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Final
544
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Saint Vincents Hospital - Darlinghurst
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Mater Adult Hospital - Brisbane
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Prince Charles Hospital - Chermside
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Royal Brisbane and Women's Hospital - Herston
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Royal Adelaide Hospital - Adelaide
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The Alfred Hospital - Melbourne
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Sir Charles Gairdner Hospital - Nedlands
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Royal Perth Hospital - Perth
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2050 - Camperdown
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2139 - Concord
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2010 - Darlinghurst
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4000 - Brisbane
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4032 - Chermside
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4029 - Herston
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5000 - Adelaide
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3004 - Melbourne
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6009 - Nedlands
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Recruitment postcode(s) [10]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
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Trial website
https://clinicaltrials.gov/study/NCT01769196
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Trial related presentations / publications
Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7. Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA. Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK. Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Soo...
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Journal
Raghu G, Brown K, Collard H, Lederer D, Martinez F...
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Journal
Raghu G, Brown KK, Collard HR, Lederer DJ, Martine...
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Results are available at
https://clinicaltrials.gov/study/NCT01769196
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