Ferinject® in Patient With Thrombocytosis Secondary to Inflammatory Bowel Disease (IBD)

This study has been terminated.
(Main objective of study was met. Further recruitment was difficult.)
Sponsor:
Information provided by:
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT00882414
First received: April 15, 2009
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Thrombocytosis
Iron-Deficiency Anemia
Drug: FERINJECT® (Ferric carboxymaltose)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • To evaluate the efficacy of FERINJECT® in reducing elevated platelet counts [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    The primary efficacy endpoint is a decrease of the platelet counts >25% after 6 weeks.


Secondary Outcome Measures:
  • Normalization of platelet levels [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    Normalization of platelet levels

  • Change in platelet activation markers (p-selectin, sCD40L), thrombopoietin and reticulated thrombocytes [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    Change in platelet activation markers (p-selectin, sCD40L), thrombopoietin and reticulated thrombocytes

  • Change in coagulation parameters (PTT, PT, factors of the intrinsic coagulation pathway) [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    Change in coagulation parameters (PTT, PT, factors of the intrinsic coagulation pathway)

  • Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin) [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin)

  • Change in quality of life (IBDQ, SF-36, FACT-An or similar) and disease activity [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    Change in quality of life (IBDQ, SF-36, FACT-An or similar) and disease activity (CDAI, CAI=Clinical activity scores (Rachmilewitz) without endoscopy)

  • Change in C-reactive protein, ESR, IL-3, IL-6 and IL-11 and calprotectin. [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: No ]
    Change in C-reactive protein, ESR, IL-3, IL-6 and IL-11 and calprotectin.

  • Adverse Events [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: Yes ]
    Adverse Events (AE): type, nature, incidence and outcome.

  • Vital signs [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: Yes ]
    Vital signs (axillary temperature, blood pressure and heart rate).

  • Physical examinations [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: Yes ]
    Physical examinations

  • Clinical laboratory panels [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: Yes ]
    Clinical laboratory panels (haematology/coagulation, clinical chemistry/inflammation, urinalysis).

  • Discontinuation of treatment due to AEs [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: Yes ]
    • Discontinuation of treatment due to AEs

  • Pregnancy test [ Time Frame: Visit 4 ] [ Designated as safety issue: Yes ]
    Pregnancy test

  • CDAI/CAI [ Time Frame: 6 weeks post baseline ] [ Designated as safety issue: Yes ]
    CDAI/CAI


Enrollment: 26
Study Start Date: December 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: ThromboVIT Placebo
Patients will receive 1 placebo infusion of 100ml 0.9% sodium chloride every 7 days for a total of 3 infusions.
Drug: Placebo
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.
Other Names:
  • NaCl 0.9%
  • saline
Experimental: ThromboVIT 1000
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.
Drug: FERINJECT® (Ferric carboxymaltose)
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.
Other Name: FERINJECT®
Experimental: ThromboVIT 1500
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).
Drug: FERINJECT® (Ferric carboxymaltose)
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.
Other Name: FERINJECT®
Experimental: ThromboVIT 500
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.
Drug: FERINJECT® (Ferric carboxymaltose)
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.
Other Name: FERINJECT®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882414

Locations
Austria
Univ. clinic for Internal Medicine
Vienna, Austria, 1090
Sponsors and Collaborators
Vifor Inc.
Investigators
Principal Investigator: Christoph Gasche, MD Allgemeines KrankenHaus, Vienna, Austria
  More Information

No publications provided

Responsible Party: Lise Riopel PhD/Clinical Indication Leader, Vifor (International) Inc
ClinicalTrials.gov Identifier: NCT00882414     History of Changes
Other Study ID Numbers: THROMBOVIT
Study First Received: April 15, 2009
Last Updated: April 7, 2010
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Vifor Inc.:
ferric carboxymaltose
platelet
thrombocyte
ferritin
hemoglobin
transferrin

Additional relevant MeSH terms:
Anemia
Inflammatory Bowel Diseases
Intestinal Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Thrombocytosis
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Blood Platelet Disorders
Myeloproliferative Disorders
Bone Marrow Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014