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

NCT00882414 | Terminated Phase 2

• 1 other identifier: THROMBOVIT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombocytosis; Iron-Deficiency Anemia

Keywords

ferric carboxymaltose; platelet; thrombocyte; ferritin; hemoglobin; transferrin

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks post baseline

Secondary Outcomes (13)

• Normalization of platelet levels

  6 weeks post baseline

• Change in platelet activation markers (p-selectin, sCD40L), thrombopoietin and reticulated thrombocytes

  6 weeks post baseline

• Change in coagulation parameters (PTT, PT, factors of the intrinsic coagulation pathway)

  6 weeks post baseline

• Change in iron parameters (ferritin, hemoglobin, transferrin, transferrin saturation, soluble transferrin-receptor, hepcidin)

  6 weeks post baseline

• Change in quality of life (IBDQ, SF-36, FACT-An or similar) and disease activity

  6 weeks post baseline

Study Arms (4)

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.

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.

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).

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.

Drug: FERINJECT® (Ferric carboxymaltose)

Interventions

FERINJECT® (Ferric carboxymaltose) DRUG

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.

Also known as: FERINJECT®

ThromboVIT 1000; ThromboVIT 1500; ThromboVIT 500

Placebo DRUG

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.

Also known as: NaCl 0.9%, saline

ThromboVIT Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vifor Pharma: lead

Study Sites (1)

Univ. clinic for Internal Medicine

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Thrombocytosis; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Anemia, Hypochromic; Anemia; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christoph Gasche, MD

  Allgemeines KrankenHaus, Vienna, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: December 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 8, 2010

Record last verified: 2010-04

Locations

AU (1)