Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-26 @ 3:21 PM
NCT ID:
NCT01545427
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be able to give informed consent.
* Subjects must meet preliminary criteria for scleroderma.
* Subjects must have diffuse skin involvement.
* Disease must appear to be active as measured by worsening skin score and/or increased ESR.
* Serum SGOT \< 1.5 times upper limit of normal.
* Bilirubin \< 1.5 times upper limit of normal.
* AST/ALT \< 2.5 times upper limit of normal
Exclusion Criteria:
* Any past exposure to Gleevec.
* Women of child bearing potential must be practicing an acceptable form of contraception (OCP, depo-provera, IUD, condoms with spermicidal or sterilization of subject or partner).
* Women who are breastfeeding.
* Men whose partners could conceive must be practicing acceptable contraception (see above).
* Certain abnormal labs including: Neutrophil count \<1.5X109/L, platelets \< 50X109/L.
* Serious comorbidity that may impair the ability to complete the study (such as severe heart disease, severe pulmonary hypertension) and other comorbidities.
* Prednisone at doses of \>10mg/od.
* Other potential disease modifying drugs such as cyclophosphamide, mycophenylate and methotrexate.
* Serious liver disease.
* Creatinine \>200.
* Excluded: Ketoconazole and fluconazole, cyclosporine, rifampin, phenytoin nefazodone, pimozide, propafenone, quinidine, sibutramine and sildenafil where drug interactions could occur.
* Subjects taking endothelin receptor blockers such as bosentan and sitaxsentan.
* Alcohol consumption of \> 3 drinks per week.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01545427
Study Brief:
Protocol Section:
NCT01545427