--- title: An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy nct_id: NCT01809314 overall_status: COMPLETED sponsor: Hoffmann-La Roche study_type: OBSERVATIONAL primary_condition: Anemia countries: Hungary canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01809314.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01809314" ct_last_update_post_date: 2016-08-19 last_seen_at: "2026-05-12T07:27:05.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy **Official Title:** Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy **NCT ID:** [NCT01809314](https://clinicaltrials.gov/study/NCT01809314) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 1167 - **Lead Sponsor:** Hoffmann-La Roche - **Conditions:** Anemia - **Start Date:** 2008-03 - **Completion Date:** 2009-10 - **CT.gov Last Update:** 2016-08-19 ## Brief Summary This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * Adults greater than or equal to (≥) 18 years of age * Participants with solid tumors or lymphoproliferative disease * Participants receiving chemotherapy * Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (\<) 11 g/dL or 6.83 millimoles per liter (mmol/L) * ECOG performance status of 0, 1, or 2 Exclusion Criteria: * Resistant hypertension * Acute chronic bleeding within 3 months prior to study * Iron deficiency that is unmanageable prior to study * Hypersensitivity to the active substance or any of the excipients of the product * Pregnant or breastfeeding women * Epoetin treatment within 6 months prior to study ``` ## Arms - **NeoRecormon in Symptomatic Anemia** — Participants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study. ## Interventions - **Epoetin beta** (DRUG) — Treatment will be given according to standard of care and the Summary of Product Characteristics during the study. ## Primary Outcomes - **Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)** _(time frame: Baseline, Month 4)_ — The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L). ## Secondary Outcomes - **Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT** _(time frame: Baseline, Month 4)_ - **Percentage of Participants Who Required Blood Transfusions During the Study** _(time frame: Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4)_ ## Locations (42) - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Budapest, Hungary - Debrecen, Hungary - Debrecen, Hungary - Debrecen, Hungary - Deszk, Hungary - Dunaújváros, Hungary - Eger, Hungary - Farkasgyepű, Hungary - Győr, Hungary - Gyula, Hungary - Kaposvár, Hungary - Kecskemét, Hungary - Miskolc, Hungary - Miskolc, Hungary - Mosdós, Hungary - Nyíregyháza, Hungary - Pécs, Hungary - Pécs, Hungary - Pécs, Hungary - Salgótarján, Hungary - Szeged, Hungary - Szekszárd, Hungary - Székesfehérvár, Hungary - Székesfehérvár, Hungary - Szolnok, Hungary - Szolnok, Hungary - Szombathely, Hungary - Tatabánya, Hungary - Törökbálint, Hungary - Veszprém, Hungary - Zalaegerszeg, Hungary ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `locations.|szeged||hungary` — added _(2026-05-12)_ - `locations.|szekszárd||hungary` — added _(2026-05-12)_ - `locations.|székesfehérvár||hungary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|budapest||hungary` — added _(2026-05-12)_ - `locations.|debrecen||hungary` — added _(2026-05-12)_ - `locations.|deszk||hungary` — added _(2026-05-12)_ - `locations.|dunaújváros||hungary` — added _(2026-05-12)_ - `locations.|eger||hungary` — added _(2026-05-12)_ - `locations.|farkasgyepű||hungary` — added _(2026-05-12)_ - `locations.|győr||hungary` — added _(2026-05-12)_ - `locations.|gyula||hungary` — added _(2026-05-12)_ - `locations.|kaposvár||hungary` — added _(2026-05-12)_ - `locations.|kecskemét||hungary` — added _(2026-05-12)_ - `locations.|miskolc||hungary` — added _(2026-05-12)_ - `locations.|mosdós||hungary` — added _(2026-05-12)_ - `locations.|nyíregyháza||hungary` — added _(2026-05-12)_ - `locations.|pécs||hungary` — added _(2026-05-12)_ - `locations.|salgótarján||hungary` — added _(2026-05-12)_ - `locations.|szolnok||hungary` — added _(2026-05-12)_ - `locations.|szombathely||hungary` — added _(2026-05-12)_ - `locations.|tatabánya||hungary` — added _(2026-05-12)_ - `locations.|törökbálint||hungary` — added _(2026-05-12)_ - `locations.|veszprém||hungary` — added _(2026-05-12)_ - `locations.|zalaegerszeg||hungary` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01809314.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01809314* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*