- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654589
Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload
November 16, 2016 updated by: Novartis Pharmaceuticals
A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/d) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present
The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload must be due to blood transfusions.
Study Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leipzig, Germany
- Novartis Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Transfusional iron overload three to six months after HCT with no evidence of active inflammation
- History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
- Patients of either gender and age ≥ 18 years.
- Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraception , or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
Exclusion criteria:
- Non-transfusion related iron overload
- Active malignancy
- Known active viral hepatitis or known HIV positiveness
- Mean levels of alanine aminotransferase (ALT) > 5x ULN
- Treatment with any iron chelator after transplantation
- Uncontrolled systemic hypertension
- Serum creatinine > 1.5 ULN and/or serum creatinine clearance < 60 ml/min
- History of nephrotic syndrome.
- Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
- Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
- Pregnant or breast feeding patients.
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: deferasirox
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
April 2, 2008
First Submitted That Met QC Criteria
April 7, 2008
First Posted (Estimate)
April 8, 2008
Study Record Updates
Last Update Posted (Estimate)
November 17, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CICL670ADE02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Overload
-
Novartis PharmaceuticalsCompletedTransfusional Iron OverloadItaly
-
ApoPharmaCompletedTransfusional Iron OverloadEgypt, Cyprus, Oman, Saudi Arabia, Turkey
-
Novartis PharmaceuticalsCompletedChronic Iron OverloadGermany
-
Novartis PharmaceuticalsNot yet recruiting
-
Novartis PharmaceuticalsCompletedCardiac Iron OverloadTaiwan, Egypt, Thailand, Turkey, United Kingdom, Italy, Canada, Greece
-
Assiut UniversityUnknownPlatelet Changes in Cases of Iron Overload
-
ApoPharmaCompletedIron Overload Due to Repeated Red Blood Cell TransfusionsUnited States, Canada, Greece, Italy
-
Assiut UniversityUnknownPlatelet Changes in Cases of Iron Overload
-
ShireTerminatedIron Overload Due to Repeated Red Blood Cell TransfusionsCanada, United States, Thailand, Italy, United Kingdom
-
ShireTerminatedPharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation TherapyIron Overload Due to Repeated Red Blood Cell TransfusionsUnited States, Canada, Lebanon, Italy, Egypt
Clinical Trials on Deferasirox
-
Novartis PharmaceuticalsCompletedTransfusion-dependent AnemiaEgypt, Hungary, Turkey, United States, Bulgaria, Italy, Belgium, Russian Federation, Philippines, France, Malaysia, India, Oman, Panama, Lebanon, Thailand, Tunisia
-
Novartis PharmaceuticalsCompletedNon-transfusion-dependent Thalassemia | Transfusion-dependent ThalassemiaEgypt, Turkey, Thailand, Lebanon, Morocco, Saudi Arabia, Vietnam
-
DisperSol Technologies, LLCCompletedThalassemia MajorThailand, United States
-
Novartis PharmaceuticalsWithdrawnThalassemia (Transfusion Delendent)
-
Assistance Publique - Hôpitaux de ParisAssociation pour l'Etude des Fonctions Digestives (AEFD)UnknownPorphyria Cutanea TardaFrance
-
Novartis PharmaceuticalsCompletedLow and Int 1-risk Myelodysplastic SyndromeGermany, Canada, Korea, Republic of, Sweden, Spain, China, Argentina, Italy, United Kingdom, Algeria
-
NovartisCompletedBeta-Thalassemia | HemosiderosisEgypt, Lebanon, Oman, Saudi Arabia, Syrian Arab Republic
-
Novartis PharmaceuticalsCompletedNon-transfusion Dependent ThalassemiaThailand, Turkey, Italy, Greece, China, United Kingdom, Lebanon, Tunisia
-
City of Hope Medical CenterTerminatedPrimary Myelofibrosis | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Iron Overload | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell... and other conditionsUnited States
-
Crolll GmbhUniversity of Magdeburg; Estimate, GmbHCompletedNon-alcoholic Steatohepatitis | Increased Iron Storage / Disturbed DistributionGermany