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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03832946




Registration number
NCT03832946
Ethics application status
Date submitted
4/02/2019
Date registered
6/02/2019

Titles & IDs
Public title
A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Scientific title
A Randomized, 52 Week, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor.
Secondary ID [1] 0 0
2018-002664-73
Secondary ID [2] 0 0
GALACTIC-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis (IPF) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GB0139
Treatment: Drugs - Placebo

Experimental: A. GB0139 3 mg once a day - Inhalation of GB0139

Placebo comparator: B. Placebo once a day - Inhalation of Placebo


Treatment: Drugs: GB0139
GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.

Treatment: Drugs: Placebo
Placebo is administered as inhalation once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of Decline in Forced Vital Capacity (FVC)
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Number of Participants With Respiratory Related Hospitalizations
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
Timepoint [2] 0 0
52 weeks

Eligibility
Key inclusion criteria
1. Male and female subjects aged = 40 years of age with a diagnosis of IPF established during the previous five years according to ATS/ERS/Fleischner criteria.
2. Lung function parameters as follows:

1. Forced Vital Capacity (FVC) > 45% of the predicted value at screening
2. Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening
3. Subjects who currently are not being treated with nintedanib or pirfenidone; or cannot tolerate nintedanib or pirfenidone
4. Subjects must sign and date a written, IRB/EC approved informed consent form and any required authorization prior to initiation of any study procedures.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
2. Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
3. Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation.
4. Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
5. Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
6. Is likely to receive lung transplantation within the next 12 months.
7. Currently receiving nintedanib, pirfenidone, high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan). A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study.
8. Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1.
9. Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.
10. Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is longer) of initiation of screening.
11. Participating in another clinical trial, either interventional or observational.
12. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous six months, including, but not limited to, the following:

1. Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months
2. Congestive heart failure requiring hospitalization
3. Uncontrolled clinically significant arrhythmias
13. If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study during the study and within (5 half- lives plus 30 days) after last dose of the study drug; or intending to donate ova during such time period.
14. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study.
15. Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2023
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Lung Research QLD - Chermside
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Respiratory Clinical Trials - Kent Town
Recruitment hospital [4] 0 0
Institute for Respiratory Health Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [5] 0 0
TrialsWest - Spearwood
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
5067 - Kent Town
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Missouri
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New Hampshire
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Belgium
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Wallon Region
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Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Namur
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Canada
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Ontario
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Canada
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Toronto
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France
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Bobigny
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France
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Lille
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France
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Marseille
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France
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Paris
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France
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Rennes
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France
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Saint Pierre
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France
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Saint-Pierre
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France
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Strasbourg
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France
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Tours
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Georgia
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Tbilisi
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Germany
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Baden-Württemberg
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Germany
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Hessen
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Germany
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Rhine-Westphalia
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Germany
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Sachsen
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Germany
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Saxony
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Germany
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Bamberg
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Germany
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Donaustauf
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Germany
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Essen
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Germany
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Leipzig
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Germany
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Munich
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Ireland
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Dublin
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Israel
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Jerusalem
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Israel
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Kefar Sava
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Re?ovot
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Italy
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Catania
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Italy
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Milan
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Italy
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MIlan
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Italy
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Modena
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Italy
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Napoli
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Italy
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Padova
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Italy
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Palermo
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Italy
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Siena
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Italy
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Turin
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Lodz
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Malopolskie
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Pomerania
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Poznan
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Yaroslavl
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Russian Federation
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Yekaterinburg
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Spain
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Asturias
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Spain
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Cantabria
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Spain
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Galicia
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Spain
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Madrid
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Spain
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Barcelona
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Spain
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Valencia
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Ukraine
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Chernivtsi
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Ukraine
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Kyiv
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Ukraine
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Ternopil
Country [83] 0 0
Ukraine
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Vinnytsya
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Cambridgeshire
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Devon
Country [86] 0 0
United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Hampshire
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United Kingdom
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Leicestershire
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United Kingdom
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Merseyside
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United Kingdom
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Newcastle
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United Kingdom
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Nottinghamshire
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United Kingdom
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South Yorkshire
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United Kingdom
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West Midlands
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Bristol
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galecto Biotech AB
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
bioRASI, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Toby Maher, MD, PhD
Address 0 0
Keck Medicine of USC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03832946