EUCTR2007-003122-24-GB进行中（未招募）1 期
A Double-Blind Placebo-Controlled Pilot Study of the Safety and Tolerability of AIMSPRO in established Diffuse Cutaneous Systemic Sclerosis - Pilot study of AIMSPRO in diffuse cutaneous systemic sclerosis
Daval International Limited0 个研究点目标入组 20 人开始时间: 2008年2月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Men and women over 18 years of age.
- •Diffuse cutaneous scleroderma (according to the 1980 ACR crtieria) with greater than three years since first non-Raynaud's manifestation.
- •Men and women of childbearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for six months after receiving the last injection of AIMSPRO®.
- •The screening laboratory test results must meet the following minimum criteria:
- •Haemoglobin8.5 g/dL
- •WBC3.5 x 109/L
- •Neutrophils1.5 x 109/L
- •Platelets 100 x 109/L
- •AST and alkaline phosphatase levels must be greater than 2 x ULN for the laboratory conducting the test.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Able voluntarily to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women who are pregnant, nursing, or planning pregnancy within one and a half years after screening (i.e., approximately six months following last injection)
- •Use of any investigational drug within one month prior to screening or within five half-lives of the investigational agent, whichever is longer.
- •Treatment with any therapeutic agent targeted at reducing TNF (e.g., infliximab, pentoxifylline, thalidomide, etanercept, etc.) within three months of screening.
- •Previous administration of AIMSPRO.
- •History of known allergy to animal proteins.
- •Serious infections such as pneumonia or pyelonephritis in the previous three months. Less serious infections such as acute upper respiratory tract infection (cold) or simple urinary tract infection should be followed to their conclusion or treated, as appropriate, prior to inclusion.
- •Opportunistic infections including, but not limited to, evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, histoplasmosis or atypical mycobacterium infection, etc, within the previous six months.
- •Active tuberculosis.
- •Presence of a transplanted organ (with the exception of a corneal transplant > three months prior to screening).
- •History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
- •Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.
- •Malignancy within the last 5 years.
- •Severe, progressive or uncontrolled renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease.
- •Myocardial infarction, uncontrolled congestive cardiac failure, unstable angina, hypotension or hypertension within the past three months.
研究者
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