The new AEGIS-1, and AEGIS-2 studies are aiming to find out whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in non-active ulcerative colitis (UC), and non-active Crohn’s disease (CD).
Summary
For people with ulcerative colitis (UC) or Crohn’s disease (CD), iron deficiency anaemia (IDA) is a common problem. Symptoms such as chronic fatigue and frequent headaches can have a significant impact on quality of life, so effective management of IDA is important as part of the wider management of UC and CD.
Up to a third of people with UC or CD suffer from frequent episodes of anaemia. A first treatment for mild-to-moderate IDA is typically an oral ferrous product (OFP) such as ferrous sulphate, however this type of treatment is often not successful as many people find they cannot take the treatment, they experience side effects in the digestive system (gastrointestinal tract) , or the treatment fails to work well enough. Common side effects of OFPs include nausea, digestive discomfort and constipation, all of which are particularly impacting and relevant for people with UC and CD.
Rather than OPFs, some of the early data gathered with ST10-021 appears to suggest that more people may tolerate this treatment meaning there could be less digestive side effects from this treatment. and this treatment could be potentially useful for people with UC or CD.
Detailed study information
Official titles:
- Ulcerative Colitis:‘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).
- Crohn’s disease:‘A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2)’
Methodology: Participants in the studies (the population) are selected according to inclusion and exclusion criteria. The studies will only include patients who have been unable to take OFPs in the past, or where it is not suitable for them. The participants are randomly placed into either an intervention group (the participant receives the treatment – ST10-021), or a control group (the participant receives a placebo – a sugar pill used for comparison). The studies are double-blind (neither the participants, not the researchers know which group each participant is in), and the studies aim to discover both the effectiveness, and safety of the potential treatment.
Measures and Metrics: The studies will involve measuring any changes in haemoglobin concentrations in the blood for 12 weeks, together with a range of other measures.
Timescales: Each of the two studies will involve about 120 participants, and will be open from August 2011. The studies will be complete around December 2012.
More information from ClinicalTrials.gov
- AEGIS 1: Clinical trial ID: NCT01340872. More information from the US National Institutes of Health: http://clinicaltrials.gov/ct2/show/NCT01340872
- AEGIS 2: Clinical trial ID: NCT01352221. More information from the US National Institutes of Health: http://clinicaltrials.gov/ct2/show/NCT01352221