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:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT00418132
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of scleroderma
* Agrees to use an effective form of contraception for 1 month prior to study entry, throughout the study, and for 60 days after completing the study
* Positive serum anti-nuclear antibody titer
Exclusion Criteria:
* Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents or with other connective tissue diseases
* Significant existing damage to any of the following internal organs:
* Kidneys, defined as a serum creatinine level greater than 2 mg/dl or renal crisis
* Lungs, defined as needing supplemental oxygen
* Heart, defined as left ventricular ejection fraction less than or equal to 40%
* Gut, defined as pseudo-obstruction or malabsorption requiring total parental nutrition
* Concurrent interventional therapy that might independently influence the outcome of this trial (e.g., D-penicillamine, cyclosporine, interferon-γ, methotrexate, or photophorosis)
* Clinically significant and inadequately medically treated concurrent endocrine, blood, liver, lung, or kidney diseases
* Pregnant
* Recent drug or alcohol abuse
* Documented noncompliance
* Significant psychiatric history
* Therapy with another investigational drug within 4 weeks prior to study entry
* Screening laboratory results exceeding the following limits: hemoglobin level less than 7 gm/dl; white blood cell level less than 3,000/nl; platelet count less than 50/nl; alanine aminotransferase (ALT) level greater than 65 U/L; creatinine level greater than 2 mg/dl
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00418132
Study Brief:
Protocol Section:
NCT00418132