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Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia

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ClinicalTrials.gov Identifier: NCT01374373
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : April 7, 2016
Sponsor:
Collaborator:
IC RESEARCH GROUP
Information provided by (Responsible Party):
Bio Sidus SA

June 13, 2011
June 16, 2011
April 7, 2016
June 2011
November 2014   (Final data collection date for primary outcome measure)
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events [ Time Frame: Baseline to 12 weeks ]
Same as current
Complete list of historical versions of study NCT01374373 on ClinicalTrials.gov Archive Site
  • Hemoglobin levels and percentage of responders [ Time Frame: Every 4 weeks and 12 weeks ]
    Evaluate efficacy assessing hemoglobin levels and percentage of responders (increments of Hemoglobin ≥ 1g/dl without transfusion requirements) comparing baseline with final 12 week and intermediate 4 week visits
  • Quality of life [ Time Frame: 12 Weeks ]
    Evaluate if treatment impacts quality of life assessed through the Brief Fatigue Index (BFI) score comparing baseline with final 12 week visit
  • Hemoglobin levels ≥ 2 g/dl [ Time Frame: 12 weeks ]
    Evaluate proportion of patient that achieve hemoglobin levels ≥ 2 g/dl without transfusion requirements and the number of patients that require at least one transfusion after 12 weeks of therapy
  • Hemoglobin levels and percentage of responders [ Time Frame: Every 4 weeks and 12 weeks ]
    Evaluate efficacy assessing hemoglobin levels and percentage of responders (increments of Hb ≥ 1g/dl without transfusion requirements) comparing baseline with final 12 week and intermediate 4 week visits
  • Quality of life [ Time Frame: 12 Weeks ]
    Evaluate if treatment impacts quality of life assessed through the BFI fatigue score comparing baseline with final 12 week visit
  • Hemoglobin levels ≥ 2 g/dl [ Time Frame: 12 weeks ]
    Evaluate proportion of patient that achieve hemoglobin levels ≥ 2 g/dl without transfusion requirements and the number of patients that require at least one transfusion after 12 weeks of therapy
Not Provided
Not Provided
 
Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.
Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Antineoplastic Chemotherapy Induced Anemia
Biological: Epoetin alfa
Epoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD
Open Label
One arm open label
Intervention: Biological: Epoetin alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
November 2014
November 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of non curable cancer or lymphoma
  • Receiving a palliative chemotherapy regimen
  • Hemoglobin < 10.0 g/dL
  • Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status
  • Life expectancy of ≥ 3 months
  • Postmenopausal o premenopausal women receiving effective contraceptive method

Exclusion Criteria:

  • Active bleeding that may have caused anemia in the prior 30 days.
  • Uncontrolled hypertension
  • Anemia for another cause other than cancer or chemotherapy
  • Untreated iron or folic acid deficiency
  • Transfusion in the last 30 days prior to baseline visit
  • Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit
  • Increased risk of thromboembolic disease
  • Radiotherapy in pelvis or spine in the last 60 days
  • Myelodysplasic syndrome
  • History of congestive heart failure
  • Pregnant or lactating
  • Patient with known allergy to human albumin or related products
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
 
NCT01374373
BIOS-012010
No
Not Provided
Not Provided
Bio Sidus SA
Bio Sidus SA
IC RESEARCH GROUP
Study Director: Roberto Diez, MD Bio Sidus SA
Bio Sidus SA
April 2016

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