NCT01623453终止不适用
A Follow-up Study to Evaluate the Sustained Healing Effect the Patients Who Showed Complete Closure of Fistula the Previous ANTG-ASC-210 Study
Anterogen Co., Ltd.2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of patients with Sustained efficacy of complete closure of fistula
研究概览
简要总结
This is an open follow-up clinical trial to evaluate a sustained efficacy and safety of ANTG-ASC injection for 4 months (6 months after final dose injection) after Phase II clinical trial.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients who have participated in ANTG-ASC-210 clinical trial
- •the patients with complete closure at week 8 after last injection in ANTG-ASC-210 trials
- •the patients who submit written informed consents and is able to obey requirements of trials
排除标准
- •a patient who has a history of variant Creutzfeldt Jacobs disease or related diseases
- •a patient who is allergic to anesthetics, bovine derived proteins or a fibrin glue
- •a patient who has an autoimmune disease
- •a patient who has infectious diseases such as hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- •a patient who has a symptom of septicemia or active tuberculosis (contain tuberculosis of anus and rectum)
- •a patient who is pregnant or breast feeding
- •a patient who is not willing to use effective contraceptive methods during the study
- •a patient who has inflammatory Bowel disease
- •a patient who is sensitive to fibrin glue
- •a patient who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker (who smoked more than 20 cigarettes a day)
- •a patient who is not able to understand the objective of this study or to comply with the study requirements
- •a patient who is considered to have a significant disease which can impact the study by investigator
- •a patient who is considered not suitable for the study by investigator
- •a patient who had a history of surgery for malignant tumor within the last five years (except carcinoma in situ)
- •a patient who has multisystemic wasting syndrome (such as tuberculosis, Diabetes, Thyroid disorders, tumor, etc.)
- •a patient who has taken cytotoxic drugs (such as immunosuppressants, corticosteroid, cytotoxic chemotherapy, anticoagulants, etc.) during long-term
结局指标
主要结局
Number of patients with Sustained efficacy of complete closure of fistula
时间窗: Month 4
Proportion of patients with completely closed of fistula (Month 4)
次要结局
- Evaluation of Fecal Incontinence Score(Month 4)
- Number of patients with adverse events as a measure of systemic tolerance and physical examinations(Month 2, 4)
- Number of patients with sustained efficacy of closure of fistula(Month 2, 4)
- Grade of Investigator's satisfaction(Month 2, 4)
研究者
研究点 (2)
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