Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox
This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01394029
First received: July 12, 2011
Last updated: November 26, 2012
Last verified: November 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 12, 2011 | ||||
| Last Updated Date | November 26, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01394029 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observation of Patients With Transfusional Hemosiderosis Treatment With Deferasirox | ||||
| Official Title ICMJE | International Sentinel Site Surveillance of Patients With Transfusional Hemosiderosis Treated With Deferasirox in Actual Practice Setting | ||||
| Brief Summary | This study will observe patients with transfusional hemosiderosis treated with deferasirox in actual practice setting. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information. |
||||
| Condition ICMJE | Transfusional Hemosiderosis | ||||
| Intervention ICMJE | Drug: deferasirox
Other Name: ICL670 |
||||
| Study Group/Cohort (s) | deferasirox
deferasirox
Intervention: Drug: deferasirox |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: -Patients treated with deferasirox for transfusional hemosiderosis according to the local prescribing information. (the patients are either beginning treatment with deferasirox at the time of enrollment in the sentinel site monitoring or are currently under treatment with deferasirox and have started the treatment under prescription up to twelve months prior to enrollment in the sentinal site monitoring. Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. |
||||
| Gender | Both | ||||
| Ages | 2 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Jordan, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01394029 | ||||
| Other Study ID Numbers ICMJE | CICL670A2301 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Novartis | ||||
| Verification Date | November 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||