EUCTR2006-000720-13-DE进行中（未招募）不适用
Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- 性别
- All
入选标准
- •1. Signed informed consent,
- •2. Man or woman between 18 and 75 years of age,
- •3. Established diagnosis of Crohn’s disease (CD) confirmed by endoscopic and histological, or endoscopic and radiological criteria, all of which since
- •at least 3 months prior to screening,
- •4. Localisation of CD either in terminal ileum (L1), in colon (L2) or
- •ileocolitis (L3), all without upper gastrointestinal involvement (- L4)
- •according to the Montreal classification (2005),
- •5. CDAI =220 and = 350 at baseline,
- •6. Serum CRP level = 2 x upper limit of normal (ULN) or stool calprotectin
- •> ULN at screening,
- •7. Haemoglobin = 10 g/dl at screening,
- •8. White blood cell count = 13.0 Gpt/L at screening,
- •9. Platelet count = lower limit of normal at screening,
- •10. Negative pregnancy test in females of childbearing potential,
- •11. Women of child-bearing potential have to apply during the entire duration
- •of the study a highly effective method of birth control, which is defined as
- •those which result in a low failure rate (i.e., less than 1% per year) when
- •used constantly and correctly such as implants, injectables, combined oral
- •contraceptive method, or some IUDs. The investigator is responsible for
- •determining whether the subject has this adequate birth control for study
- •participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 376
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Known Crohn’s lesions in the upper GI-tract (up to and including the
- •jejunum) with present symptoms,
- •2. Bowel surgery within the last 3 months prior to baseline,
- •3. Resection of more than 50 cm of the ileum,
- •4. Ileostomy or colostomy,
- •5. Septic complications,
- •6. Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium
- •difficile toxin in stool culture),
- •7. Abscess, perforation, active fistulas, or active perianal lesions,
- •8. Immediate surgery required (e.g., major stenosis, serious bleeding,
- •peritonitis, ileus),
- •9. Clinical signs of stricturing disease,
- •10. Parenteral or tube feeding,
- •11. Abnormal hepatic function (ALT or ALP > 2.5 x ULN at screening), liver
- •cirrhosis, or portal hypertension,
- •12. Abnormal renal function (Cystatin C > ULN) at screening,
- •13. Acute EBV infection at screening,
- •14. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric
- •disorder, which in the opinion of the investigator might have an influence
- •on the patient’s compliance or the interpretation of the results,
- •15. Any condition associated with significant immunosuppression,
- •16. Active malignancy or treatment with anticancer drugs during the last
- •5 years. Patients with a history of cancer and at least five years of
- •uneventful follow up and no signs of recurrence may be eligible as well as
- •patients with treated, non-metastatic cancers (e.g., basalioma),
- •17. Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-
- •a agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine,
- •methotrexate, tacrolimus, cyclophosphamide, or cyclosporine within the
- •last 3 months prior to baseline,
- •18. Treatment with antibiotics (e.g., metronidazole or ciprofloxacin),
- •antiparasitic medications within the last 2 weeks prior to baseline,
- •19. Treatment with topical or systemic glucocorticosteroid within the last 4 weeks prior to baseline, or within the last 8 weeks, if patients have been
- •treated for longer than 3 months,
- •20. Patients known to be steroid-dependent or refractory, as defined in ECCO
- •consensus guideline 2010,
- •21. Patients being unresponsive to both treatment with a biologic (e.g., anti-
- •TNF-a agents or anti-integrin agents) AND treatment with a thiopurine
- •(i.e., azathioprine, 6-MP, or 6-thioguanine),
- •22. Application of non-steroidal anti-inflammatory drugs (NSAIDs) within
- •2 weeks before baseline visit for more than 3 consecutive days, except
- •acetylsalicylic acid = 350 mg/d which is allowed,
- •23. Immunisation with live vaccines within 12 weeks prior to baseline or
- •during the study,
- •24. Travelling within the last 12 weeks prior to baseline or during study
- •participation to countries outside of Europe, U.S.A., or Canada,
- •25. Well-founded doubt about the patient’s cooperation, e.g., because of
- •addiction to alcohol or drugs,
- •26. Existing or intended pregnancy or breast-feeding,
- •27. Participation in another clinical trial within the last 30 days, simultaneous
- •participation in another clinical trial, or previous participation in the
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