Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Atlantic Pharmaceuticals Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Written informed consent;
2. Male or female subjects, 18 years of age who have undergone an IPAA for UC
3. History of pouchitis
4. Overall PDAI score \> 7
5. Must have Chronic Antibiotic Refractory Pouchitis
You may not be if
1. Lack of effective contraception
2. Women who are pregnant or breastfeeding;
3. Strong analgesia NSAID use
4. Change in dose of the following permitted meds during screening and study: oral 5-aminosalicylate (5 ASA), Oral steroids,, Immunosuppressant therapy.
5. Rectal products
6. Biological agents: Anti-tumour necrosis factor (anti - TNF) therapy and / or vedolizumab; are not permitted within 8 weeks of the Screening Visit.
7. 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)
8. Anal sphincter dysfunction
9. Infections to cytomegalovirus or Clostridium Difficile
10. Other GI pathology (inc. intestinal malabsorption, pancreatic maldigestion etc) and differential diagnoses
11. Clinically significant and/or persistent illness; which in the investigators opinion, would exclude entry into the trial
Clareo Health | Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
