Nivestim(TM) in Treatment of Malignant Diseases
| Tracking Information | |||||
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| First Received Date ICMJE | June 7, 2012 | ||||
| Last Updated Date | January 9, 2013 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Any incidence of hospitalization due to febrile neutropenia and/or infection will be evaluated. Individual cases will be reported and documented on SAE forms by the repsonsible physician. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01627990 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nivestim(TM) in Treatment of Malignant Diseases | ||||
| Official Title ICMJE | The Compatibility of Nivestim(TM) Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases | ||||
| Brief Summary | This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN). |
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| Detailed Description | To observe the tolerability, safety and efficacy of preventative treatment using NivestimTM in patients receiving cytotoxic chemotherapy for cancer. To investigate the description of the characteristics of patients being treated with NivestimTM, the treatment modalities using NivestimTM in the daily Routine, to investigate the description of the characteristics of the participating Physicians and to determine the general prescription practices of these physicians with regard to G-CSF. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children and adult patients with a solid tumor or a malignant haematological tumor due to under go prophylatic treatment using Nivestim/ |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 700 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01627990 | ||||
| Other Study ID Numbers ICMJE | VENICE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hospira, Inc. | ||||
| Study Sponsor ICMJE | Hospira, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hospira, Inc. | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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