patients with IBD and chronic fatigue MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: ferinject
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Ferric Carboxymaltose
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man and women, 18 years of age or older. - Female subjects must utilize a highly effective method of birth control throughout the study. - At least 12-month history of IBD. - Inactive Crohn’s disease or Ulcerative colitis (HB: 13). - Concurrent stable doses of 5-aminosalicylate, azathioprine, methotrexate or anti TNFa. - Iron deficiency: ferritin=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Known hypersensitivity to iron sucrose or to its excipients. - Pregnancy: women with childbearing potential must not become pregnant during the study. - Clinically active IBD and /or C-reactive protein >2.5. - Comorbidity possibly resulting in (additional) fatigue (e.g., kidney or adrenal insufficiency, autoimmune diseases, malignancy, depression, a recent viral infection, or psychotrauma psychic diseases, included depression. - Anaemia (Hb:< 12.5 in male and < 11.5 in female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: chronic fatigue remission (MFI-20 13;Primary end point(s): chronic fatigue remission;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): chronic fatigue response;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Italy
Contacts
Public ContactUfficio Sperimentazioni Cliniche
Istituto Clinico Humanitas
Outcome results
None listed