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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01881529




Registration number
NCT01881529
Ethics application status
Date submitted
5/06/2013
Date registered
19/06/2013
Date last updated
17/04/2014

Titles & IDs
Public title
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
Scientific title
A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
Secondary ID [1] 0 0
GS-US-321-0108
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Limited Scleroderma 0 0
Diffuse Scleroderma 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Limited Scleroderma -

Diffuse Scleroderma -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summarized the number and percentage of subjects with elevated LOXL2 levels
Timepoint [1] 0 0
Baseline

Eligibility
Key inclusion criteria
- Over 18 years of age

- Documented diagnosis of scleroderma

- Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of experimental therapies within 28 days prior to Screening.

- Aspirin use > 81 mg daily within 1 week prior to Screening.

- Any lab abnormality or concurrent medical condition that, in the opinion of the
investigator would make the patient ineligible for the study

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Centre for Applied Medical Research - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To treat patients with scleroderma by blocking the expression of LOXL2. The investigators
first need to confirm (through observation) that LOXL2 is overexpressed in disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01881529
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bittoo Kanwar, MD
Address 0 0
Gilead Sciences
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01881529