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

NCT ID: NCT01881529

Last Updated: 2014-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Limited Scleroderma Diffuse Scleroderma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Limited Scleroderma

No interventions assigned to this group

Diffuse Scleroderma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bittoo Kanwar, MD

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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St Vincent's Centre for Applied Medical Research

Darlinghurst, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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GS-US-321-0108

Identifier Type: -

Identifier Source: org_study_id

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