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OpenTrials
Completed

NCT Number: NCT01626547

Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.

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Key information

About this study

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age ≥18 years .
  • Patients present with chemotherapy-induced symptomatic anaemia.
  • Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
  • The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
  • Patients eligible for epoetin alfa biosimilar treatment.

Exclusion criteria

  • Patients are not receiving chemotherapy.
  • Patients already included in an epoetin zeta study.
  • Patients presenting with the contraindications to epoetin zeta.
  • Patients presenting with the hypersensitivity to the active substance or any of the excipients.
  • The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
  • Patients with uncontrolled hypertension.
  • Patients who cannot receive adequate prophylaxis by antithrombotic agents.

Treatment and study plan

Primary outcomes

  1. Change and corrected Hemoglobin levels

    Time frame: 6 months

    Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.

Secondary outcomes

  1. Observation of blood value development

    Time frame: 6 months

    Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation

  2. Evaluation of the profiles of treated patients

    Time frame: 6 months

  3. Evaluation of prescriber's therapy plan

    Time frame: 6 months

  4. Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics

    Time frame: 6 months

  5. Observation of the tolerability profile of Epoetin Zeta

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 22, 2012
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.