ST10-021 for IDA in quiescent UC
Research type
Research Study
Full title
A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1).
IRAS ID
76251
Contact name
Andy Li
Sponsor organisation
Iron Therapeutics (Switzerland) AG
Eudract number
2010-023588-16
Clinicaltrials.gov Identifier
Research summary
Ulcerative colitis (UC) is a disease involving inflammation of the large intestine, and as such it is grouped under the general term of inflammatory bowel disease. Symptoms of UC include diarrhoea, abdominal pain, fever, signs of an intestinal obstruction, and/or passage of blood from the rectum. Remission refers to a disease becoming inactive for a period of time, and patients with UC experience periods of remission and relapse of the disease. To be eligible for this study, patients must have inactive or minimally active UC. A lack of iron in the blood is defined as iron deficiency anaemia (IDA). IDA is a serious complication and a key symptom of UC. Patients with UC commonly present with anaemia because of inadequate absorption of iron in the intestine, and because of blood loss. Oral iron therapy is a common treatment for IDA. At the current time, oral iron therapy is available as ferrous iron, which in chemical terms is Fe2. Ferrous iron is not efficiently absorbed in the intestine, and unabsorbed iron commonly causes adverse effects such as nausea, abdominal pain, and constipation. Thus, patients taking oral ferrous iron commonly experience worsening of their UC symptoms. Iron therapies can be injected directly into the blood, however, this can have side effects including pain, infection from the line, or a serious allergic reaction to the iron.It is anticipated that the study drug, ST10-021, a new form of oral iron therapy, will be better tolerated compared with currently available oral iron therapies. This randomised study will investigate the tolerability and effectiveness in improving iron levels in the blood from study start to Week 12 in patients receiving ST10-021 versus placebo. Patients can participate if they have previously failed or cannot use oral ferrous therapies, and have a current diagnosis of non-active or minimally active UC.
REC name
London - Riverside Research Ethics Committee
REC reference
11/LO/0804
Date of REC Opinion
2 Aug 2011
REC opinion
Further Information Favourable Opinion