Extension Study on Efficacy and Safety of Deferasirox Treatment in Patients With Beta-thalassemia and Transfusional Hemosiderosis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 25, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Liver Iron Concentration measured by liver MRI (or if not practicable liver biopsy) [ Time Frame: at 1 and 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To allow patients treated with ICL670 in the core protocol to continue iron chelation therapy
To evaluate the long-term safety and tolerability profile of ICL670

Change History

Complete list of historical versions of study NCT00171301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ongoing monitoring and recording of all adverse events and serious adverse events [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
Hematology, blood chemistry and urine renal function values at monthly intervals [ Time Frame: monthly ] [ Designated as safety issue: No ]
surrogate markers, such as serum ferritin, serum iron, serum transferrin (TRF) and transferrin saturation at monthly intervals [ Time Frame: monthly ] [ Designated as safety issue: No ]
Measurement of vital signs and performance of physical examinations at 12-weekly intervals [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
Total body iron excretion rate (estimated based on the iron influx as determined by the amount of red cells transfused and the change in total body iron stores) at 1-year and 2-years [ Time Frame: At 1 year & at 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To estimate the absolute and relative changes of liver iron content (LIC)
To evaluate the role of serum ferritin and other surrogate markers
To assess drug usage compliance

Descriptive Information

Brief Title ^ICMJE

Extension Study on Efficacy and Safety of Deferasirox Treatment in Patients With Beta-thalassemia and Transfusional Hemosiderosis

Official Title ^ICMJE

Extension Study on Efficacy and Safety of Deferasirox Treatment in Patients With Beta-thalassemia and Transfusional Hemosiderosis

Brief Summary

Because patients with beta-thalassemia are unable to actively eliminate iron from the body, toxic and eventually lethal levels of iron can accumulate as a result of repeated blood transfusions. This study is a 1-year extension study and will evaluate the long-term efficacy, safety and tolerability of deferasirox.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Beta-thalassemia Major

Intervention ^ICMJE

Drug: ICL670; deferasirox

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

247

Completion Date

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients completing the planned 12-month core study
Female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation

Exclusion Criteria:

Pregnant or breast feeding patients.
Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the core study protocol, or the planned extension protocol

Gender

Both

Ages

3 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Lebanon

Administrative Information

NCT ID ^ICMJE

NCT00171301

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CICL670A2402E1

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP