Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )

Shield Therapeutics

Status: Completed

Conditions: Anemia, Iron Deficiency; Inflammatory Bowel Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT03247816

ST10-01-401

Details and patient eligibility

About

The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability.

Full description

The aim of the study is to understand the early experiences of Feraccru® in patients with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including treatment effectiveness, patterns of use and tolerability. By describing the characteristics of patients treated with Feraccru® and their outcomes, this study will provide the medical community with important information to support treatment decisions for their patients. This will ultimately support improvements to patient care, including the long-term outcomes of patients with IBD and IDA

Enrollment: 59 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged ≥ 18 years at the time of initiation .
• Patient presenting with mild to moderate IDA that is secondary to either Crohn's disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and <13.0 g/dL in males, or Hb ≥9.5 g/dL and <12.0 g/dL in females
• Serum ferritin concentration <30 microgram/L or transferrin saturation of <20% .
• Patient receiving Feraccru® since the time of UK launch in June 2016.

Exclusion criteria

• Patient receiving Feraccru® as part of an interventional clinical trial.
• Patients with severely active IBD or requiring corticosteroids at the time of initiation on Feraccru®.
• Patient with an IBD flare, as determined by the clinician.
• Patient with medical records that are not available for review.
• Patient not willing or unable to consent to study participation, or patient is deceased at the start of data collection period

Trial design