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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01943968
Other study ID # HYMC-075-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 12, 2013
Last updated September 12, 2013
Start date December 2013
Est. completion date June 2014

Study information

Verified date September 2013
Source Hillel Yaffe Medical Center
Contact Karina Zilber, MD
Phone 972-54-7870716
Email karinazilber@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic sclerosis. The results obtained may help us diagnose these complications of systemic sclerosis and hopefully even monitor patient treatment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Systemic Sclerosis Patients

- Written consent to participation in study

Exclusion Criteria:

- Serious active medical condition

- Other autoimmune rheumatic disease

- Current or past allergic/inflammatory reaction

- Liver disease

- Pregnant or breastfeeding

- Illegal drug or alcohol abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Other:
Blood test


Locations

Country Name City State
Israel Bnai Zion Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fibrin Enzyme Levels in Blood Patients will undergo blood tests before study and after six months to determine levels of lysyl oxidase, semaphorin 7a and 3a and thus determine severity of the disease (systemic sclerosis). Six months No
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