AnemiaPhase 3NCT00548860
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
A Phase 3 study testing Ferric Carboxymaltose and Standard Medical Care (SMC) in people with Anemia, run by American Regent, Inc. at 1 site in United States.
Trial summary
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anemia
- What is being tested?
- Ferric Carboxymaltose and Standard Medical Care (SMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,018 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female with iron deficiency anemia
- Hg </= 11 g/dL
Who cannot join
- Previous participation in a FCM trial
- Known Hypersensitivity to FCM
- History of anemia other that anemia due to heavy uterine bleeding or the post partum state
- current history of GI bleeding
- Received IV Iron within the month prior
- Anticipated need for surgery
Show all 10Show fewer
- Malignancy history
- AST or ALT greater than normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually active females who are not willing ot use an effective form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals
Norristown, Pennsylvania, 19403
About this study
Official title: A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
- Conditions
- Anemia
- Being tested
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CarboxymaltoseDrug
Standard Medical Care (SMC)Drug
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) Receives: Drug: Ferric Carboxymaltose |
| Standard Medical Care (SMC) | Active comparator | Varied as determined by the Investigator Receives: Drug: Standard Medical Care (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).
Measured: From Day 0 through 30 days after the last dose of study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- 2,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548860
- Sponsor's protocol ID
- 1VIT07017
- Status last verified
- Jan 2018
- First submitted
- 22 Oct 2007
- Last updated
- 20 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.
PubMed 28487769
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
- ClinicalTrials.gov ID
- NCT00548860
- Acronym / sponsor ID
- 1VIT07017
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,018 participants (actual)
- Lead sponsor
- American Regent, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Oct 2007 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | Drug: Ferric CarboxymaltoseUndiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) |
| Standard Medical Care (SMC) | Active comparator | Drug: Standard Medical Care (SMC)Varied as determined by the Investigator |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Female with iron deficiency anemia
- Hg </= 11 g/dL
Key exclusion criteria (10 listed)
- Previous participation in a FCM trial
- Known Hypersensitivity to FCM
- History of anemia other that anemia due to heavy uterine bleeding or the post partum state
- current history of GI bleeding
- Received IV Iron within the month prior
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 |
|---|---|---|
| Ferric Carboxymaltose | Drug | Ferric Carboxymaltose (FCM) |
| Standard Medical Care (SMC) | Drug | Standard Medical Care (SMC) |
Primary outcome
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.
Time frame: From Day 0 through 30 days after the last dose of study drug.
Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28487769Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Carboxymaltose and Standard Medical Care (SMC) in people with Anemia, run by American Regent, Inc. at 1 site in United States.
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 2 inclusion and 10 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 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. (time frame: From Day 0 through 30 days after the last dose of study drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00548860, which also lists 1 linked publication.
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 20 Feb 2018.