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A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01881529
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease
Limited Scleroderma Diffuse Scleroderma

Detailed Description:
Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
Study Start Date : April 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Limited Scleroderma
Diffuse Scleroderma

Primary Outcome Measures :
  1. Summarized the number and percentage of subjects with elevated LOXL2 levels [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
  • 5 mL blood draw for LOXL2 testing
  • 2 Punch Skin Biopsies (one near the scleroderma lesion, the other from normal skin)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with documented diagnoses of scleroderma will be enrolled into one of two cohorts, depending upon the subject's diagnosis

Inclusion Criteria:

  • Over 18 years of age
  • Documented diagnosis of scleroderma
  • Willing and able to provide written informed consent

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01881529

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Australia, New South Wales
St Vincent's Centre for Applied Medical Research
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Gilead Sciences
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Study Director: Bittoo Kanwar, MD Gilead Sciences

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Responsible Party: Gilead Sciences Identifier: NCT01881529     History of Changes
Other Study ID Numbers: GS-US-321-0108
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014
Keywords provided by Gilead Sciences:
limited scleroderma
diffuse scleroderma
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Scleroderma, Limited
Connective Tissue Diseases
Skin Diseases