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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02517151
Other study ID # 868
Secondary ID
Status Recruiting
Phase Phase 2
First received August 4, 2015
Last updated September 9, 2015
Start date October 2014
Est. completion date December 2016

Study information

Verified date September 2015
Source Istituto Clinico Humanitas
Contact Silvio Danese, MD, PhD
Phone +39 02 8224
Email IBDclinicaltrials@humanitas.it
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial Summary

A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.


Description:

The study will evaluate a 6 months therapy with intravenous ferric carboxymaltose.

Patients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.

At every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).

Study team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date December 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Diagnosis of Ulcerative Colitis or Crohn's Disease established at least 6 months prior to Day 1 by endoscopy and/or imaging

- At least 6 months of clinical remission (Harvey Bradshaw Index =5; Mayo clinical score = 2)

- Therapy with mesalamine, immunosuppressors or anti-tumor necrosis factor alpha (TNFa) at stable doses for at least 3 months prior enrollment; steroids are not permitted from 6 months prior baseline

- Chronic fatigue symptoms (MFI-20>13)

- Iron deficiency: ferritin < 100 microg/l or < 300 microg/l in case of Transferrin-Iron Saturation Percentage (TSAT) <20%

- Women of childbearing potential must have a negative serum pregnancy test before enrollment.

- Able and willing to provide written informed consent

Exclusion Criteria:

- Known hypersensibility to active principle or excipients

- Pregnant or lactating women

- Clinically active IBD (Harvey Bradshaw Index >6; Mayo clinical score >3 or C-Reactive Protein >2.5 mg/L

- Renal failure (eGFR<60)

- History of adrenal insufficiency

- History of autoimmune diseases

- History of malignancies

- Depression

- Any current or recent signs or symptoms of viral infectious diseases

- Recent psycho-traumatic events

- Hemoglobin levels < 12.5 g/dl (men) or <11.5 g/dL (women)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Ferric carboxymaltose

Placebo


Locations

Country Name City State
Italy IBD Center Rozzano MI

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary chronic fatigue remission Multidimensional fatigue inventory (MFI-20) <13 Week 24 No
Secondary Chronic fatigue reduction MFI-20 reduction of at least 4 points (absolute MFI-20>13) Week 24 No
Secondary chronic fatigue remission MFI-20 <13 Week 12 No
Secondary Anxiety evaluation State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values week 4, week 12, week 24 No
Secondary Depression evaluation BECK DEPRESSION INVENTORY (BDI-II) values week 4, week 12, week 24 No
Secondary Quality of life Inflammatory Bowel Disease Questionnaire (IBDQ) values week 4, week 12, week 24 No
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