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

Diffuse Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881529
• Other study ID #: GS-US-321-0108
• Status: Completed
• Phase: N/A
• First received: June 5, 2013
• Last updated: April 16, 2014
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diffuse Scleroderma
• Limited Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Limited
• Scleroderma, Localized
• Scleroderma, Systemic

Locations

Country	Name	City	State
Australia	St Vincent's Centre for Applied Medical Research	Darlinghurst	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summarized the number and percentage of subjects with elevated LOXL2 levels		Baseline	No