Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis

UMIN ID: UMIN000000589

Registered date:14/02/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: systemic sclerosis (SSc)
• Date of first enrollment: 2007/02/01
• Target sample size: 8
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Granulocyte-colony stimulating factor (G-CSF), "Gran&quot

Outcome(s)

• Primary Outcome: Digital ulcers at the 24 weeks
• Secondary Outcome: The number of circulating endothelial precursors in the peripheral blood, Raynaud's core set, safety

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Medical history of allergic reactions to G-CSF derivation or other recombinant proteins produced in E.coli Patient diagnosed as having myeloid leukemia, myelodysplastic syndrome and other hematopoietic malignancies Patient with severe liver, renal, and/or cardio-respiratory dysfunctions Patient with severe splenomegaly Patient with thrombopenia ( <100,000 / microliter) Medical history of thromboembolism ( cerebrovascular disease, ishemic heart disease, deep vein thrombosis, pulmonary thromboembolism )

Related Information

• Primary Sponsor: Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: Health Labour Sciences Research Grant,None