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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.
ClinicalTrials.gov Identifier: NCT01881529
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Study Design

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
Primary Completion Date : March 2014
Study Completion Date : March 2014


Groups and Cohorts

Group/Cohort
Limited Scleroderma
Diffuse Scleroderma


Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01881529


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

Responsible Party: Gilead Sciences
ClinicalTrials.gov 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
Sclerosis
Progressive
Limited

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Scleroderma, Limited
Connective Tissue Diseases
Skin Diseases