An Open Label, Multi-Center, Randomized, Two Arm, Phase III Clinical Trial toEvaluate Efficacy and Safety of Thymosin alpha one plus Standard of Care (SOC) in Comparisonwith SOC Alone in Patients with Confirmed Endometriosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- combination with SOC versus SOC alone in patients with
研究概览
简要总结
Endometriosis is defined as the presence of endometrial glands and stroma-like lesions outside of the uterus The cause of endometriosis is still unclear but an increasing number of studies have been investigated the role of immune system in its etiology and pathogenesis Thymosin α 1 has a wide range of biological activities that range from anti-tumor to immune- modulating properties. Thymosin α 1 looks a potential treatment that can be dosed in combination with standard of care in patients with endometriosis
Total 120 Eligible patients will be enrolled in 1:1 ratio in two arms ( 60 Patients in each arm) 90 days for treatment and another 90 days for follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients between the age group ≥18and ≤ 49 years of age at the time of consent
- •Patients with a confirmed diagnosis of Endometriosis (up to stage III) based on laparoscopy or imaging
- •Patients having negative urine pregnancy test at the time of screening and agree to the use of barrier contraception during the study period
- •Patients who are willing to comply with study procedures and restrictions
- •Patients who can and are willing to provide signed informed consent.
排除标准
- •Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial ablation resulting in amenorrhea
- •Candidate for elective gynaecological surgery [Dilation and Curettage (D&C), cervical cryosurgery, colposcopy, Loop Electrosurgical Extension Procedure (LEEP)] for next 6 months
- •Patient who had a normal or C section delivery with a gap of less than 3 months after cessation of Lactation
- •Participation in other clinical trials in last three months and during study period
- •Patients having an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes
- •Patients having a history of positive human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at Screening or have a history of a positive result
- •Pregnant and lactating female lactating at the time of screening and willing to continue lactating during the study
- •Any other condition, which as per the investigator would jeopardize the outcome of the trial
- •Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
结局指标
主要结局
combination with SOC versus SOC alone in patients with
时间窗: Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180
To evaluate and compare the efficacy of Thymosin α 1 in
时间窗: Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180
endometriosis in terms of endometriosis associated pain assessed by a
时间窗: Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180
Visual Analogue Scale (VAS) score
时间窗: Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180
次要结局
- • To evaluate and compare the efficacy of Thymosin α 1 in(combination with SOC versus SOC alone in patients with)