Inflammatory Bowel DiseasePhase 3NCT01017614
Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
A Phase 3 study testing Monofer and Iron Sulphate in people with Inflammatory Bowel Disease, run by Pharmacosmos A/S at 10 sites in 3 countries.
Trial summary
The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Monofer and Iron Sulphate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Oct 2009to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:
- Men and women, aged more than 18 years.
- Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis).
- Hb <12.0 g/dL (7.45 mmol/L).
- Transferrin saturation (TfS) <20 %.
Who cannot join
- Anaemia predominantly caused by other factors than iron deficiency anaemia.
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
- Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate).
- Known hypersensitivity to any excipients in the investigational drug products.
- Subjects with a history of multiple allergies.
- Active Intestinal Tuberculosis.
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- Active Intestinal amoebic infections.
- Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper limit normal).
- Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)).
- Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- Pregnancy and nursing
- Extensive active bleeding necessitating blood transfusion.
- Planned elective surgery during the study.
- Participation in any other clinical study within 3 months prior to screening.
- Intolerance to oral iron treatment.
- Untreated B12 or folate deficiency.
- Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- Erythropoetin treatment within 8 weeks prior to screening visit.
- Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.
- Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
- History of immunocompromise, including positive HIV test result
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
India6 sites
Research Site
Hyderabad
Research Site
Jaipur
Research Site
Mumbai
Research Site
Nashik
Research Site
New Delhi
Research Site
Pune
Denmark3 sites
Research Site
Aalborg
Research Site
Aarhus
Research Site
Copenhagen
About this study
Official title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Oligosaccharide (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).
Read the detailed description
The study is designed to determine the effects of an investigational drug Monofer in subjects with Inflammatory Bowel Disease (IBD) (an intestinal disease characterized by swelling, redness and sometimes ulcers in intestine) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood in the body).
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Monofer, Iron Sulphate
- Keywords
- Inflammatory Bowel Disease, Iron deficiency, Iron deficiency anaemia, Anaemia
- Medical subject headings
- Inflammatory Bowel Diseases, Iron Deficiencies, Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoferDrug
- administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained
- administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained
Iron SulphateDrug
200 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Monofer | Experimental | * administered as intravenous infusions (A1)
* administered as intravenous bolus injections (A2) Receives: Drug: Monofer |
| Iron Sulphate | Active comparator | tablets administered orally Receives: Drug: Iron Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hb concentration from baseline to week 8.
Measured: 8 weeks
Secondary outcomes (1)
Number of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL and have serum ferritin (100-800µg/L) and have achieved Transferrin saturation (TfS) (20-50 %) at week 2, 4 and 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Max Neeman International
- Investigators
- Pharmacosmos A/S, Study chair, Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017614
- Sponsor's protocol ID
- P-Monofer-IBD-01
- Other IDs
- EudraCT no 2009-012544-16
- Status last verified
- Nov 2012
- First submitted
- 19 Nov 2009
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Oligosaccharide (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
- ClinicalTrials.gov ID
- NCT01017614
- Acronym / sponsor ID
- P-Monofer-IBD-01
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, Iron deficiency, Iron deficiency anaemia, Anaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- Max Neeman International
- Study start
- Oct 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).
Detailed description
The study is designed to determine the effects of an investigational drug Monofer in subjects with Inflammatory Bowel Disease (IBD) (an intestinal disease characterized by swelling, redness and sometimes ulcers in intestine) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood in the body).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monofer | Experimental | Drug: Monofer* administered as intravenous infusions (A1) * administered as intravenous bolus injections (A2) |
| Iron Sulphate | Active comparator | Drug: Iron Sulphatetablets administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following criteria:
- Men and women, aged more than 18 years.
- Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis).
- Hb <12.0 g/dL (7.45 mmol/L).
- Transferrin saturation (TfS) <20 %.
Key exclusion criteria (21 listed)
- Anaemia predominantly caused by other factors than iron deficiency anaemia.
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
- Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate).
- Known hypersensitivity to any excipients in the investigational drug products.
- Subjects with a history of multiple allergies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monofer* administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained * administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained | Drug | Monofer |
| Iron Sulphate200 mg daily | Drug | Iron Sulphate |
Primary outcome
Change in Hb concentration from baseline to week 8.
Time frame: 8 weeks
1 secondary outcome
Number of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL and have serum ferritin (100-800µg/L) and have achieved Transferrin saturation (TfS) (20-50 %) at week 2, 4 and 8.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pharmacosmos A/S study chair
Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Monofer and Iron Sulphate in people with Inflammatory Bowel Disease, run by Pharmacosmos A/S at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hb concentration from baseline to week 8. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.