EUCTR2013-002952-34-IT进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic,Antibiotic Refractory Primary Idiopathic Pouchitis - ACH-UCP-301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 138
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. Written informed consent;
- •2. Male or female subjects, 18 years of age who have undergone an IPAA for UC
- •3. History of pouchitis
- •Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
- •4. Endoscopic score = 2 on the endoscopic component of a modified MAYO score (where friability is scored as = 2) Note: the area within 1 cm of the pouch staple, or pouch suture line, is
- •not considered evaluable
- •5. Symptomatic disease (stool frequency): Subjects must demonstrate increased stool frequency compared to what is considered normal
- •after their IPAA operation (baseline). Stool frequency must be an absolute value of = 6 stools per day, and = 3 stools per day above the
- •post-IPAA baseline. Note: The measurement of stool frequency will be a 7-day average
- •rounded to the nearest integer. The most recent 7 days of data will be used to calculate the average.
- •6. Histology: evidence of disease (Score = 2 on PDAI)
- •7. Overall PDAI score > 7
- •8. Must have Chronic Antibiotic Refractory Pouchitis
- •Chronic Antibiotic Refractory Pouchitis is defined as remaining in active disease despite antibiotic therapy for at least 2 continuous weeks. There
- •is no requirement for antibiotic use to be current, or within a defined time-window. Antibiotics must be stopped 4 weeks before the Randomizaton visit which is effectively 2 weeks before the screening visit. As a minimum the antibiotic regime will comprise ciprofloxacin 1g/day, or metronidazole 15 – 20 mg/kg/day. Patients must have been
- •in active disease for a minimum of 4 weeks at the point of randomisation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •1. Lack of effective contraception
- •2. Women who are pregnant or breastfeeding;
- •3. History of allergy or adverse event to oligonucleotides including alicaforsen hidroxymethylcellulose, methyl
- •or propylparabens.
- •4. Change in dose to strong analgesia, such as opioid containing compounds within 4 weeks of the screening visit.
- •5. History of regular NSAID use.
- •6. Oral 5-aminosalicylate (5-ASA) compounds; exclude subjects who have discontinued or changed doses of oral 5-ASA within 4 weeks of the
- •Screening Visit.
- •7. Oral budesonide > 6.0 mg / day is not permitted; exclude subjects who have received budesonide for < 6 weeks, or who have changed doses of budesonide within 4 weeks of the Screening Visit.
- •8. Oral steroids other than budesonide; exclude subjects who exceed a daily dose of 15 mg prednisolone or equivalent, who have received oral
- •steroids for < 6 weeks, or who have changed dose within 4 weeks of the Screening Visit.
- •9. Use of rectal compounds is not permitted; these agents must be discontinued at the Screening Visit.
- •10. Immunosuppressant therapy (azathioprine, 6-mercaptopurine, methotrexate, cyclosporin); exclude subjects who have received treatment for < 12 weeks, or who have changed doses within 8 weeks of the Screening Visit.
- •11. Biological agents: Anti-tumour necrosis factor (anti – TNF) therapyand / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
- •12. Previous use of alicaforsen is permitted: treatment course must have completed at least 12 weeks prior to the Screening Visit. (Alicaforsen
- •pre-treated subjects may not contribute to the primary efficacy analysis.)
- •13. All other agents targeted to pouchitis, including experimental agents,must have been discontinued at least 8 weeks prior to the Screening
- •Visit, or for a period equivalent to 5 half-lives (t½) of the agent (whichever is longer)
- •14. Anastomotic stricture
- •15. Unable to undertake endoscopic evaluation
- •16. Faecal incontinence due to anal sphincter dysfunction
- •17. Infections to cytomegalovirus or Clostridium Difficile
- •18. Faecal transplantation within 12 weeks of screening.
- •19. Intestinal malabsorption
- •20. Pancreatic maldigestion
- •21. Suspected irritable pouch syndrome
- •22. Cuffitis (inflammation of the anal mucosa).
- •Subjects with active antibiotic refractory pouchitis as the predominant condition, but who also have cuffitis, may be enrolled
- •23. Crohn's disease of the pouch: defined as either:a)complex perianal or pouch fistula and/or b) extensive pre-pouch ileitis with deep ulceration.
- •24. Subjects with a history of neoplastic disease except for basal cellcarcinoma or non-metastatic squamous cell carcinoma of the skin
- •25. Subjects who are receiving or have received nasogastric/nasoenteric bottle feeding, an elemental diet, or total parenteral nutrition within the 2 weeks prior to Day 1
- •26. Subjects with a history of clinically significant and/or persistent hhaematologic, renal hepatic, metabolic, psychiatric, CNS, pulmonary or cardiovascular disease; which in the investigators opinion, would exclude entry into the study
- •27. Subjects with any laboratory tests considered clinically significant at screening
- •28. Subjects who may be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by
- •the Investigator for any other reason including, for example, inability to retain an enema formulation
- •29. Pelvic sepsis should be excluded as a differential diagnosis, within 12 months of randomization
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