ACTRN12608000241336尚未招募2 期
A Randomized, Double-Blind, Placebo-Controlled, Trial Of Asp1002 (Trichuris Suis Ova [Tso]) Therapy For Moderately Active Crohn’s Disease
Asphelia Pharmaceuticals Inc.0 个研究点目标入组 60 人开始时间: 2008年5月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1. Diagnosis of CD involving the ileum, colon, or ileum and colon of
- •at least 6 months in duration as determined by medical history
- •2. CDAI (Crohn's Disease Activity Index)= 220 and = 350, as scored from 7 days during the
- •Screening period
- •3. Must have had colonoscopy with no significant findings and with
- •findings consistent with CD within 6 months of study entry
- •4. Male or female, age 18 to 70 years, inclusive
- •5. If on the following medications at Screening Visit 1, patients must
- •meet the following criteria:
- •a. Corticosteroids: stable treatment for at least 4 weeks prior to
- •study entry (Week 0) with a maximum dose of 15 mg/day
- •b. Immunosuppressants [azathioprine (AZA),
- •6-mercaptopurine (6-MP), methotrexate (MTX)]: treatment
- •for at least 3 months with a stable dose for four weeks prior to
- •study entry (Week 0)
- •c. Antibiotics: ciprofloxacin can be continued at a stable dose
- •for up to two weeks if the patient is on treatment at Screening
- •d. Anti-inflammatory: Mesalamine can be continued if the
- •patient has been on a stable dose (up to 1.2 gms/daily) for 6
- •weeks prior to study entry (Week 0)
- •6. Able to read, understand, and sign an ethics committee approved
- •informed consent form
排除标准
- •1. Patients whose CD was diagnosed more than 5 years ago
- •2. Patients whose CD is anticipated to require surgical, endoscopic,
- •or radiologic intervention while on study
- •3. Hospitalization for CD within the last 2 months or at risk for
- •hospitalization secondary to CD within the next 2 months
- •4. CD requiring total parental nutrition (TPN)
- •5. Evidence of bowel obstruction within 3 months of Screening
- •6. Symptomatic stricture of the small or large intestine within 3
- •months of study entry (Week 0)
- •7. Active fistula not adequately drained or non-perianal fistula
- •8. Intestinal or abdominal abscess
- •9. History of bowel resection of any length in the last 6 months from
- •study entry (Week 0) or total bowel resection(s) > 100 cm.
- •Patients with total bowel resection(s) = 100 cm can be enrolled
- •provided that the Screening fecal calprotectin level is 100 mcg/g
- •feces to confirm that the bowel symptoms (i.e., diarrhea) are
- •linked to CD and not to short bowel syndrome.
- •10. Ileostomy or colostomy
- •11. Uncontrolled gastrointestinal (GI) bleeding
- •12. Short bowel syndrome
- •13. Diagnosis of ulcerative colitis
- •14. Scleroderma
- •15. Asthma necessitating daily controller medication
- •16. Clinically detectable splenomegaly
- •17. Positive stool culture for C difficile toxin A or B, bacterial enteric
- •pathogens, rotavirus, cryptosporidium species or pathogenic
- •ova/parasites
- •18. Co-infection with Campylobacter jejuni
- •19. Women, who are pregnant, breast feeding or planning to become
- •pregnant during the study. All women of childbearing potential
- •must have a negative serum pregnancy test prior to study entry
- •20. Men and women of children bearing potential not using adequate
- •birth control measures (e.g., abstinence, oral contraceptives,
- •intrauterine device, barrier method with spermicide, or surgical
- •sterilization)
- •21. Current or recent serious systemic disorder including clinically
- •significant impairment in cardiac, pulmonary, liver, renal,
- •endocrine, hematologic, or neurologic function
- •22. Positive for human immunodeficiency virus (HIV)
- •23. Any condition associated with significant immunosuppression
- •24. Patients currently receiving the following concomitant
- •medications:
- •a. Prednisone or its equivalent, greater than 15 mg/day
- •b. Local steroids such as budesonide, Colifoam, and Predsol
- •c. Non-steroidal anti-inflammatory drugs (NSAIDS),
- •Cyclooxygenase (COX)-2 inhibitors, or aspirin
- •>100 mg/day within 1 week of study entry (Week 0)
- •d. TNF-alpha inhibitors such as infliximab (Remicade®),
- •adalimumab (Humira®) or other biological agents within 3
- •months of study entry (Week 0)
- 另有 16 项未显示
研究者
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