ThrombocytosisPhase 2NCT00882414
Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)
A Phase 2 study testing FERINJECT® (Ferric carboxymaltose) in people with Thrombocytosis and Iron-Deficiency Anemia, run by Vifor Pharma at 1 site in Austria.
Trial summary
The aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thrombocytosis, Iron-Deficiency Anemia
- What is being tested?
- FERINJECT® (Ferric carboxymaltose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2006to Jan 2010
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, inpatient or outpatient, aged at least 18 years and not more than 60 years.
- Have a platelet count >450G/l
- Transferrin saturation (TfS) <20% or ferritin < 100µg/l
- Previously diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Females of child-bearing potential must have a negative urine pregnancy test at screening and be practicing a highly effective method of birth control during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilized at least 6 months prior to the study or postmenopausal, defined as amenorrhoea for at least 12 months.
- Demonstrate the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to undergo the required assessments.
Who cannot join
- CDAI >220, CAI>6
- Significant anemia (hemoglobin <10.5 g/dl), or anaemia not caused by iron deficiency (e.g. anaemia due to cancer or infection)
- Blood transfusions or iron therapy during the previous 4 weeks, or erythropoietin treatment within the 8 weeks prior to enrollment.
- Concomitant therapy with prednisolone above 20mg/d, 6-mercaptopurine, infliximab or azathioprine must have been initiated at least 4 months prior to study and the dose must be stable for at least 8 weeks. Other drugs with known effects on megakaryopoiesis (e.g. interferon-alpha).
- Severe concomitant disease or need for surgery within 8 weeks
- Hemochromatosis or other iron-storage disorders (e.g. thalassemia, siderosis, lead poisoning anaemia, porphyria cutanea tarda)
Show all 13Show fewer
- Treatment with an investigational drug within the 30 days prior to enrollment
- Active severe infection or malignancy other than carcinoma in situ of the cervix and non-melanoma skin cancer.
- Bone Marrow Disease (MDS, thalassemia, etc)
- Active or chronic liver or kidney disease. Serum albumin <25 g/L or serum creatinine >20 mg/L
- Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator. Known hypersensitivity to FERINJECT®
- Positive for HIV 1/HIV 2 antibodies (anti HIV) (HIV: human immunodeficiency virus).
- Positive for hepatitis B surface-antigen (HBsAg), hepatitis C virus antibody (anti HCV) and evidence for active hepatitis, i.e., abnormal liver function test (LFT) results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Randomized, Controlled, Single-blinded, Phase II Study to Investigate the Safety and Efficacy of Intravenous Infusions of FERINJECT® Versus Placebo in Patients With Thrombocytosis Secondary to Iron Deficiency and Chronic Inflammatory Bowel Disease
The aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
Read the detailed description
For the first time a platelet abnormality in IBD was reported in 1968, with a description of an increased platelet count in patients having an exacerbation of clinical activity 1. Since then it has been established that thrombocytosis and platelet activation are common features in IBD2. Both features are strongly connected to thromboembolic events, which are a major cause of patient morbidity and mortality 3. In vitro studies have so far shown that spontaneous platelet aggregation is present in more than 30% of IBD patients compared to none of the controls and besides independent of disease severity 4.
Unfortunately the mechanisms behind the abnormal megakaryopoiesis are not completely understood. Nevertheless platelets can store and produce a large amount of inflammatory mediators and are activated by multiple proinflammatory substances. Therefore, platelets are regarded as a major target in the therapy of inflammatory bowel diseases 5. An increase in systemic cytokine levels such as IL-6 or IL-11 may contribute to enhanced platelet production. Also intestinal bleeding and iron deficiency, which are major symptoms of IBD, may have stimulatory effects on megakaryopoiesis 6.
Previously, we observed a normalization of elevated platelet counts in IBD patients with iron deficiency anemia (IDA) upon treatment with intravenous iron sucrose 7. We therefore believe that iron deficiency is causatively involved in the pathogenesis of thrombocytosis in IBD and intend to investigate the effect of intravenous iron therapy on platelet levels and platelet activation markers in patients with IBD and iron deficiency.
Vifor (International) Inc. has developed a new formulation of parenteral iron, FERINJECT® (5% w/v iron carboxymaltose in a solution of water for injection). Based on preclinical toxicity data and clinical experience, FERINJECT® does not cause anaphylactic reactions or liver toxicity. Based on human pharmacokinetic data, the estimated terminal half-life of FERINJECT® is 16 hours. The analysis of a FERINJECT® positron emission tomography (PET) study in six patients each receiving a single dose of 100mg iron as FERINJECT® demonstrated that, during the initial distribution phase, a major proportion of the dose was distributed to the bone marrow . Red cell utilization of iron was found to be high. After 24 days, patients with IDA showed a red cell utilization of 91% to 99%. Various studies demonstrated that FERINJECT® could be safely administered at doses of up to 1000mg, which is a significant advantage of FERINJECT® over iron sucrose.
A multiple-dose phase I/II study in patients with IBD investigating the safety, efficacy, and kinetics of repeated doses of FERINJECT® has been completed. Patients who were treated at our unit (Medical University of Vienna) were also analyzed regarding the effect of VIT45 on platelet counts. Similar to our experience with iron sucrose, we observed a significant drop in thrombocytosis within 8 weeks pointing again to the direct effect of iron on regulating megakaryopoiesis in vivo8.
This study tries to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
As with all iron preparations, overdosing with respect to the total amount should be avoided. The maximum infused weekly dose of FERINJECT® will be 500 mg. Based on animal toxicity data and patient experience, FERINJECT® does not cause anaphylactic reactions or liver toxicity at the doses intended for use in this study. However, due to the relatively large doses of iron being administered, patients will be monitored carefully throughout the study for symptoms of iron overload.
Potential benefits to the patients include a decrease of the platelet counts, besides a increase in hemoglobin levels and normalization of iron stores.
Primary Objective:
To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts
Secondary Objectives:
To evaluate the effect of FERINJECT® on coagulation and platelet activation parameters To evaluate the efficacy of FERINJECT® in normalizing iron deficiency To evaluate the change of quality in life and disease activity To evaluate the safety of FERINJECT®
- Conditions
- Thrombocytosis, Iron-Deficiency Anemia
- Being tested
- FERINJECT® (Ferric carboxymaltose), Placebo
- Keywords
- ferric carboxymaltose, platelet, thrombocyte, ferritin, hemoglobin, transferrin
- Medical subject headings
- Thrombocytosis, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FERINJECT® (Ferric carboxymaltose)Drug
Also called FERINJECT®
FERINJECT® will be administered i.v. into a peripheral vein in the arm. 500 mg FERINJECT® will be diluted to a total volume of 100mL in 0.9% saline for infusion and administered over 15 minutes duration.
PlaceboDrug
Also called NaCl 0.9%, saline
Placebo will be administered i.v. into a peripheral vein in the arm. A total volume of 100mL 0.9% saline will be administered over 15 minutes duration.
| Study group | Role | What they receive |
|---|---|---|
| ThromboVIT Placebo | Placebo comparator | Patients will receive 1 placebo infusion of 100ml 0.9% sodium chloride every 7 days for a total of 3 infusions. Receives: Drug: Placebo |
| ThromboVIT 1000 | Experimental | ThromboVIT 1000: Patients will receive 1 infusion of 500mg Ferinject® diluted in 100ml 0.9% sodium chloride every 7 days for a total of 2 infusions (1000 mg) followed by 1 placebo infusion of 100ml 0.9% sodium chloride. Receives: Drug: FERINJECT® (Ferric carboxymaltose) |
| ThromboVIT 1500 | Experimental | Patients will receive 1 infusion of 500mg Ferinject® diluted in 100ml 0.9% sodium chloride every 7 days for a total of 3 infusions (1500 mg). Receives: Drug: FERINJECT® (Ferric carboxymaltose) |
| ThromboVIT 500 | Experimental | ThromboVIT 500: Patients will receive 1 infusion of 500mg Ferinject® diluted in 100ml 0.9% sodium chloride (500 mg) followed by 2 placebo infusions of 100ml 0.9% sodium chloride every 7 days. Receives: Drug: FERINJECT® (Ferric carboxymaltose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts
The primary efficacy endpoint is a decrease of the platelet counts >25% after 6 weeks.
Measured: 6 weeks post baseline
Secondary outcomes (13)
Normalization of platelet levels
Normalization of platelet levels
Measured: 6 weeks post baseline
Change in platelet activation markers (p-selectin, sCD40L), thrombopoietin and reticulated thrombocytes
Change in platelet activation markers (p-selectin, sCD40L), thrombopoietin and reticulated thrombocytes
Measured: 6 weeks post baseline
Change in coagulation parameters (PTT, PT, factors of the intrinsic coagulation pathway)
Change in coagulation parameters (PTT, PT, factors of the intrinsic coagulation pathway)
Measured: 6 weeks post baseline
Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin)
Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin)
Measured: 6 weeks post baseline
Change in quality of life (IBDQ, SF-36, FACT-An or similar) and disease activity
Change in quality of life (IBDQ, SF-36, FACT-An or similar) and disease activity (CDAI, CAI=Clinical activity scores (Rachmilewitz) without endoscopy)
Measured: 6 weeks post baseline
Change in C-reactive protein, ESR, IL-3, IL-6 and IL-11 and calprotectin.
Change in C-reactive protein, ESR, IL-3, IL-6 and IL-11 and calprotectin.
Measured: 6 weeks post baseline
Adverse Events
Adverse Events (AE): type, nature, incidence and outcome.
Measured: 6 weeks post baseline
Vital signs
Vital signs (axillary temperature, blood pressure and heart rate).
Measured: 6 weeks post baseline
Physical examinations
Physical examinations
Measured: 6 weeks post baseline
Clinical laboratory panels
Clinical laboratory panels (haematology/coagulation, clinical chemistry/inflammation, urinalysis).
Measured: 6 weeks post baseline
Discontinuation of treatment due to AEs
- Discontinuation of treatment due to AEs
Measured: 6 weeks post baseline
Pregnancy test
Pregnancy test
Measured: Visit 4
CDAI/CAI
CDAI/CAI
Measured: 6 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startDec 2006
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Main objective of study was met. Further recruitment was difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Gasche, MD, Principal investigator, Allgemeines KrankenHaus, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882414
- Sponsor's protocol ID
- THROMBOVIT
- Status last verified
- Apr 2010
- First submitted
- 15 Apr 2009
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Controlled, Single-blinded, Phase II Study to Investigate the Safety and Efficacy of Intravenous Infusions of FERINJECT® Versus Placebo in Patients With Thrombocytosis Secondary to Iron Deficiency and Chronic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT00882414
- Acronym / sponsor ID
- THROMBOVIT
- Conditions
- Thrombocytosis, Iron-Deficiency Anemia
- Keywords
- ferric carboxymaltose, platelet, thrombocyte, ferritin, hemoglobin, transferrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Main objective of study was met. Further recruitment was difficult.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Apr 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 aim of this study is to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
Detailed description
For the first time a platelet abnormality in IBD was reported in 1968, with a description of an increased platelet count in patients having an exacerbation of clinical activity 1. Since then it has been established that thrombocytosis and platelet activation are common features in IBD2. Both features are strongly connected to thromboembolic events, which are a major cause of patient morbidity and mortality 3. In vitro studies have so far shown that spontaneous platelet aggregation is present in more than 30% of IBD patients compared to none of the controls and besides independent of disease severity 4.
Unfortunately the mechanisms behind the abnormal megakaryopoiesis are not completely understood. Nevertheless platelets can store and produce a large amount of inflammatory mediators and are activated by multiple proinflammatory substances. Therefore, platelets are regarded as a major target in the therapy of inflammatory bowel diseases 5. An increase in systemic cytokine levels such as IL-6 or IL-11 may contribute to enhanced platelet production. Also intestinal bleeding and iron deficiency, which are major symptoms of IBD, may have stimulatory effects on megakaryopoiesis 6.
Previously, we observed a normalization of elevated platelet counts in IBD patients with iron deficiency anemia (IDA) upon treatment with intravenous iron sucrose 7. We therefore believe that iron deficiency is causatively involved in the pathogenesis of thrombocytosis in IBD and intend to investigate the effect of intravenous iron therapy on platelet levels and platelet activation markers in patients with IBD and iron deficiency.
Vifor (International) Inc. has developed a new formulation of parenteral iron, FERINJECT® (5% w/v iron carboxymaltose in a solution of water for injection). Based on preclinical toxicity data and clinical experience, FERINJECT® does not cause anaphylactic reactions or liver toxicity. Based on human pharmacokinetic data, the estimated terminal half-life of FERINJECT® is 16 hours. The analysis of a FERINJECT® positron emission tomography (PET) study in six patients each receiving a single dose of 100mg iron as FERINJECT® demonstrated that, during the initial distribution phase, a major proportion of the dose was distributed to the bone marrow . Red cell utilization of iron was found to be high. After 24 days, patients with IDA showed a red cell utilization of 91% to 99%. Various studies demonstrated that FERINJECT® could be safely administered at doses of up to 1000mg, which is a significant advantage of FERINJECT® over iron sucrose.
A multiple-dose phase I/II study in patients with IBD investigating the safety, efficacy, and kinetics of repeated doses of FERINJECT® has been completed. Patients who were treated at our unit (Medical University of Vienna) were also analyzed regarding the effect of VIT45 on platelet counts. Similar to our experience with iron sucrose, we observed a significant drop in thrombocytosis within 8 weeks pointing again to the direct effect of iron on regulating megakaryopoiesis in vivo8.
This study tries to show the benefits for patients, with a high platelet count, iron deficiency and IBD, receiving intravenous iron therapy.
As with all iron preparations, overdosing with respect to the total amount should be avoided. The maximum infused weekly dose of FERINJECT® will be 500 mg. Based on animal toxicity data and patient experience, FERINJECT® does not cause anaphylactic reactions or liver toxicity at the doses intended for use in this study. However, due to the relatively large doses of iron being administered, patients will be monitored carefully throughout the study for symptoms of iron overload.
Potential benefits to the patients include a decrease of the platelet counts, besides a increase in hemoglobin levels and normalization of iron stores.
Primary Objective:
To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts
Secondary Objectives:
To evaluate the effect of FERINJECT® on coagulation and platelet activation parameters To evaluate the efficacy of FERINJECT® in normalizing iron deficiency To evaluate the change of quality in life and disease activity To evaluate the safety of FERINJECT®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ThromboVIT Placebo | Placebo comparator | Drug: PlaceboPatients will receive 1 placebo infusion of 100ml 0.9% sodium chloride every 7 days for a total of 3 infusions. |
| ThromboVIT 1000 | Experimental | Drug: FERINJECT® (Ferric carboxymaltose)ThromboVIT 1000: Patients will receive 1 infusion of 500mg Ferinject® diluted in 100ml 0.9% sodium chloride every 7 days for a total of 2 infusions (1000 mg) followed by 1 placebo infusion of 100ml 0.9% sodium chloride. |
| ThromboVIT 1500 | Experimental | Drug: FERINJECT® (Ferric carboxymaltose)Patients will receive 1 infusion of 500mg Ferinject® diluted in 100ml 0.9% sodium chloride every 7 days for a total of 3 infusions (1500 mg). |
| ThromboVIT 500 | Experimental | Drug: FERINJECT® (Ferric carboxymaltose)ThromboVIT 500: Patients will receive 1 infusion of 500mg Ferinject® diluted in 100ml 0.9% sodium chloride (500 mg) followed by 2 placebo infusions of 100ml 0.9% sodium chloride every 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, inpatient or outpatient, aged at least 18 years and not more than 60 years.
- Have a platelet count >450G/l
- Transferrin saturation (TfS) <20% or ferritin < 100µg/l
- Previously diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Females of child-bearing potential must have a negative urine pregnancy test at screening and be practicing a highly effective method of birth control during the study and for up to 1 month after the last dose of the study medication. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilized at least 6 months prior to the study or postmenopausal, defined as amenorrhoea for at least 12 months.
Key exclusion criteria (13 listed)
- CDAI >220, CAI>6
- Significant anemia (hemoglobin <10.5 g/dl), or anaemia not caused by iron deficiency (e.g. anaemia due to cancer or infection)
- Blood transfusions or iron therapy during the previous 4 weeks, or erythropoietin treatment within the 8 weeks prior to enrollment.
- Concomitant therapy with prednisolone above 20mg/d, 6-mercaptopurine, infliximab or azathioprine must have been initiated at least 4 months prior to study and the dose must be stable for at least 8 weeks. Other drugs with known effects on megakaryopoiesis (e.g. interferon-alpha).
- Severe concomitant disease or need for surgery within 8 weeks
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 |
|---|---|---|
| FERINJECT® (Ferric carboxymaltose)Also: FERINJECT®FERINJECT® will be administered i.v. into a peripheral vein in the arm. 500 mg FERINJECT® will be diluted to a total volume of 100mL in 0.9% saline for infusion and administered over 15 minutes duration. | Drug | ThromboVIT 1000, ThromboVIT 1500, ThromboVIT 500 |
| PlaceboAlso: NaCl 0.9%, salinePlacebo will be administered i.v. into a peripheral vein in the arm. A total volume of 100mL 0.9% saline will be administered over 15 minutes duration. | Drug | ThromboVIT Placebo |
Primary outcome
To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts
Time frame: 6 weeks post baseline
The primary efficacy endpoint is a decrease of the platelet counts >25% after 6 weeks.
13 secondary outcomes
Normalization of platelet levels
Time frame: 6 weeks post baseline
Change in platelet activation markers (p-selectin, sCD40L), thrombopoietin and reticulated thrombocytes
Time frame: 6 weeks post baseline
Change in coagulation parameters (PTT, PT, factors of the intrinsic coagulation pathway)
Time frame: 6 weeks post baseline
Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin)
Time frame: 6 weeks post baseline
Change in quality of life (IBDQ, SF-36, FACT-An or similar) and disease activity
Time frame: 6 weeks post baseline
Change in C-reactive protein, ESR, IL-3, IL-6 and IL-11 and calprotectin.
Time frame: 6 weeks post baseline
Adverse Events
Time frame: 6 weeks post baseline
Vital signs
Time frame: 6 weeks post baseline
Physical examinations
Time frame: 6 weeks post baseline
Clinical laboratory panels
Time frame: 6 weeks post baseline
Discontinuation of treatment due to AEs
Time frame: 6 weeks post baseline
Pregnancy test
Time frame: Visit 4
CDAI/CAI
Time frame: 6 weeks post baseline
Results and safety
The study was stopped early (reason given: Main objective of study was met. Further recruitment was difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
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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.
Christoph Gasche, MD principal investigator
Allgemeines KrankenHaus, Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FERINJECT® (Ferric carboxymaltose) in people with Thrombocytosis and Iron-Deficiency Anemia, run by Vifor Pharma at 1 site in Austria.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Apr 2010. 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 Austria. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Main objective of study was met. Further recruitment was difficult.). Results are not available in the source record.
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?
To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts (time frame: 6 weeks post baseline). 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 8 Apr 2010.