Inflammatory Bowel DiseasePhase 1NCT01213680
Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease
A Phase 1 study testing Monofer (iron isomaltoside 1000) and Monofer in people with Inflammatory Bowel Disease, run by Pharmacosmos A/S.
Trial summary
The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease 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 (iron isomaltoside 1000) and Monofer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 1
- 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
- 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)
- Weight above 50 kg
- Hb <12 g/dL (7.45 mmol/L)
- Transferrin saturation (TfS) <20%
- Life expectancy beyond 12 months by investigator's judgment
- Willingness to participate after informed consent -
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
Show all 19Show fewer
- Active intestinal amoebic infections
- Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) > 3 times upper limit normal)
- History of immunocompromise and/or history of Hepatitis B and/or C
- Acute infections (assessed by clinical judgment), supported by white blood cells (WBC) and C-reactive protein (CRP))
- Rheumatoid arthritis with symptoms or signs of active joint inflammation
- Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches)
- Extensive active bleeding necessitating blood transfusion
- Planned elective surgery during the study
- Participation in any other clinical study within 3 months prior to screening
- Untreated B12 or folate deficiency
- Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit
- Erythropoietin treatment within 4 weeks prior to screening visit
- 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
About this study
Official title: Open-label Pharmakokinetic Study of Iron Isomaltoside 1000 (Monofer)Administered by 500 mg IV Injection or 1000 mg Intravenous Infusion to Patients With Inflammatory Bowel Disease (PK-IBD-02)
The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Monofer (iron isomaltoside 1000), Monofer
- Keywords
- Inflammatory Bowel Disease, IBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofer (iron isomaltoside 1000)Drug
1000 mg iron isomaltoside administered as a infusion over 15 minutes
MonoferDrug
500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1000 mg iron isomaltoside as intravenous infusion | Active comparator | Not described Receives: Drug: Monofer (iron isomaltoside 1000) |
| 500 mg iron isomaltoside 1000 as bolus injection | Active comparator | Not described Receives: Drug: Monofer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum iron pharmakokinetic parameters
Measured: 24, 48 and72 hours
Secondary outcomes (1)
Total urine-iron pharmakokinetic parameters
Measured: 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionNov 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Lykke Thomsen, MD, Study chair, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213680
- Sponsor's protocol ID
- P-Monofer-PK-IBD-02
- Other IDs
- PK-IBD-02
- Status last verified
- Nov 2013
- First submitted
- 1 Oct 2010
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pharmakokinetic Study of Iron Isomaltoside 1000 (Monofer)Administered by 500 mg IV Injection or 1000 mg Intravenous Infusion to Patients With Inflammatory Bowel Disease (PK-IBD-02)
- ClinicalTrials.gov ID
- NCT01213680
- Acronym / sponsor ID
- P-Monofer-PK-IBD-02
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, IBD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Oct 2010 (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 this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1000 mg iron isomaltoside as intravenous infusion | Active comparator | Drug: Monofer (iron isomaltoside 1000) |
| 500 mg iron isomaltoside 1000 as bolus injection | Active comparator | Drug: Monofer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- Weight above 50 kg
- Hb <12 g/dL (7.45 mmol/L)
- Transferrin saturation (TfS) <20%
Key exclusion criteria (19 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 (iron isomaltoside 1000)1000 mg iron isomaltoside administered as a infusion over 15 minutes | Drug | 1000 mg iron isomaltoside as intravenous infusion |
| Monofer500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes | Drug | 500 mg iron isomaltoside 1000 as bolus injection |
Primary outcome
Total serum iron pharmakokinetic parameters
Time frame: 24, 48 and72 hours
1 secondary outcome
Total urine-iron pharmakokinetic parameters
Time frame: 24, 48 and 72 hours
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 14 Nov 2013.
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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.
Lars Lykke Thomsen, MD study chair
Pharmacosmos A/S
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Monofer (iron isomaltoside 1000) and Monofer in people with Inflammatory Bowel Disease, run by Pharmacosmos A/S.
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 7 inclusion and 19 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 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Total serum iron pharmakokinetic parameters (time frame: 24, 48 and72 hours). 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 14 Nov 2013.