Effect of Deferasirox on Endocrine Complications in Subjects With Transfusion Dependent Thalassemia

NCT02069886 | Withdrawn Phase 4

• 1 other identifier: CICL670AIT12
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The CENTAurus trial is a prospective clinical study designed to address systematically some of the relevant endocrine complications in an iron overloaded thalassemic population, primary objective being the assessment of the effect of deferasirox therapy on glucose metabolism/homeostasis. Other endocrine parameters complementary or supportive to the primary objective will be assessed and analyzed during this study. A number of lab parameters related to other axes of the endocrine system will be collected and analyzed.

Conditions

Thalassemia (Transfusion Delendent)

Keywords

Endocrine complications; transfusion dependent thalassemia

Outcome Measures

Primary Outcomes (1)

• Change from baseline of glucose blood level measured after 2 h after receiving a glucose-equivalent oral challenge

  The primary efficacy variable is the change (mg/dl) from baseline to 36 months of glucose plasma levels measured 2 hr post glusose equivalent oral challange. After a 12-hour overnight fasting, at zero time (baseline) blood sample will be drawn and afterwards patients will receive a glucose-equivalent oral challenge (75 grams). After glucose loading plasma samples will be drawn at 30, 60, 90, 120 minutes for determination of plasma glucose. This will be repeated every 6 month till end of study

  36 months

Secondary Outcomes (8)

• Glucose of OGTT ( AUC)

  baseline and every 6 months measurement of 2hour Glocose of OGTT

• change on insulin secretion and sensitivity

  baseline and every 6 months measurement of 2hr Glucose OGTT

• Measurement of thyroid hormones TSH and FT4

  baseline and every 12 months

• Risk factors for the impairment of glucose homeostasis

  baseline and monthly till End of Study

• Changes in endocrine funcionts parameters

  baseline and monthly till EOS

Study Arms (1)

deferasirox

EXPERIMENTAL

single arm. all patients will receive deferasirox

Drug: deferasirox

Interventions

deferasirox DRUG

125, 250, 500 mg dispersable tablets

deferasirox

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Beta thalassemia major and severe intermedia patients transfusion dependent and with transfusional iron overload 2. Patients with diagnosis of impaired fasting glucose or impaired glucose tolerance 4.Patients naïve to deferasirox or patients who already receive deferasirox at sub-optimal doses 5.Cardiac MRI T2\* \>10 msec; 7.normal cardiac function (LVEF \> 56%);

You may not qualify if:

• Non transfusional hemosiderosis;
• Patients with diabetes mellitus (genetic or secondary) or history of diabetes mellitus in 1st degree relatives;
• Patients who received organ transplant; 5.Patients with galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption; 6.Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox; 7.History of hypersensitivity to the study drug or any of its excipients; 8. Renal impairment 10. Liver impairment; 11.Patients with active chronic hepatitis B infection, active hepatitis C infection;

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Thalassemia

Interventions

Deferasirox

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 24, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 20, 2017

Record last verified: 2015-03