An Exploratory, Open Labelled, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With Clostridium Difficile-associated Diarrhea (CDAD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 9
- 主要终点
- Initial cure rate at 12 days post initiation of therapy.
研究概览
简要总结
The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea (CDAD).
详细描述
This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD. Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the end of the treatment period, patients will be followed for up to 8 weeks to assess the incidence of disease recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years or older of any gender.
- •Inpatients and/or outpatients who are able to attend all scheduled visits.
- •Patients with the first episode or the first recurrence of mild or moderate CDAD.
- •Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.
排除标准
- •Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).
- •A white blood cell count higher than 15,000 cells/mL.
- •A serum creatinine level greater than or equal to 1.5 times ULN.
- •Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.
- •Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.
- •Any other non-C difficile diarrhea.
- •Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.
- •Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).
- •Received laxatives within the previous 48 hours.
- •Pregnant or lactating women.
- •Prior (within 180 days of Screening) or current use of anti-toxin antibodies.
- •Have received a vaccine against C difficile.
- •Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.
研究组 & 干预措施
Group 1: 125mg b.i.d. for 10 days
Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
干预措施: MGB-BP-3 (Drug)
Group 2: 250mg b.i.d. for 10 days
Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
干预措施: MGB-BP-3 (Drug)
Group 3: 500mg b.i.d. for 10 days
Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
干预措施: MGB-BP-3 (Drug)
结局指标
主要结局
Initial cure rate at 12 days post initiation of therapy.
时间窗: 12 days
Initial clinical cure is defined as resolution of diarrhea (\<3 bowel movements with unformed stools within 24 hours \[Type 5, 6, or 7 bowel movement on the Bristol Stool Chart\] for patients for 2 consecutive days), maintained for the subsequent duration of therapy (1 day of exacerbation and then return to the resolved state is acceptable), with no further requirement for CDAD therapy, assessed by EOT and sustained for 2 days after the end of the 10-day initial treatment course.
Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
时间窗: 40 days
Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
次要结局
- Time to peak plasma concentration (Tmax).(10 days)
- CDAD Recurrence(Up to 8 weeks)
- Peak plasma concentration (Cmax).(10 days)