Skip to main content
OpenTrials
Completed

NCT Number: NCT02140736

Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology

The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Agen, France

Loading trial locations.

About this study

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin 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 of more than 18 years of age
  • Patients presenting with anemia following chemotherapy
  • Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following 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 trial
  • Patients presenting with a contraindication to epoetin zeta
  • Patients presenting with hypersensitivity to the active principle or any of the excipients
  • Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
  • Patient with uncontrollable arterial hypertension
  • Patients who cannot receive adequate prophylaxis by antithrombotic agents

Treatment and study plan

Epoetin biosimilar

Drug

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. Observe evolution of the biological indicators

    Time frame: 6 months

    Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation

  2. Study the profiles of treated patients

    Time frame: 6 months

  3. Assess the reasons for the prescriber's treatment regimens

    Time frame: 6 months

  4. Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics

    Time frame: 6 months

  5. Observation of the safety profiles of the Product (Epoetin Alfa)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

Acronym: ORHEO

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 16, 2014
Registry last updated
Feb 28, 2024

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.