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AnemiaPhase 3NCT00711958

Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients

A Phase 3 study testing HX575, solution for injection (s.c.) and ERYPO®, Janssen-Cilag, solution for injection (s.c.) in people with Anemia, run by Sandoz at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged >18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
HX575, solution for injection (s.c.) and ERYPO®, Janssen-Cilag, solution for injection (s.c.)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
19 sitesin 2 countries
Study dates
Nov 2004to Dec 2005
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a confirmed diagnosis of solid tumors
  • Patients who receive cyclic palliative chemotherapy with a cycle duration of 1 -4 weeks (for at least 12 weeks) during the study
  • Patients with chemotherapy associated anemia (hemoglobin < 10.0 g/dl at screening)
  • Life expectancy of at least 6 months Age: > 18
  • Eastern Cooperative Oncology Group performance status of 0, 1 or 2
  • Serum ferritin greater or equal to 100 µg/l and/or saturated transferrin levels greater or equal to 20 %
Show all 10Show fewer
  • Adequate renal function (serum creatinine below or equal to 2.0 mg/dl)
  • Adequate hepatic function (bilirubin < 1.5 times upper limit of normal range
  • Patients with ability to follow study instructions, likely to complete all required visits and able to perform the quality of life assessment
  • Written informed consent of the patient

Who cannot join

  • Patients who receive curative intended chemotherapy
  • Known primary or metastatic malignancy of the central nervous system
  • Known primary or metastatic malignancy of bone marrow
  • Primary hematologic disorder (e.g. myelodysplastic syndrome, sickle cell anemia, hematological malignancy, acute leukemia)
  • Thrombotic events during the last 6 months
  • Suspicion or known PRCA (pure red cell aplasia)
Show all 24Show fewer
  • Transfusion of white blood cells or packed red blood cells (more than 2 packs) within 4 weeks and any transfusion of white blood cells or packed red blood cells within 2 weeks prior to randomization (visit 0)
  • Anemia due to overt bleeding or hemolysis within 2 weeks before screening
  • Erythropoietin or Darbepoietin therapy within 8 weeks before screening, including any investigational form of erythropoietin (e.g. gene-activated erythropoietin, novel erythropoiesis stimulating protein)
  • Radiation therapy during the study, radiation therapy induced anemia
  • Therapy with cyclosporine
  • Chemotherapy which causes predictable treatment with peripheral-blood progenitor therapy, e.g. G-CSF
  • Clinical evidence of current uncontrolled hyperparathyroidism (serum parathyroid hormone >1500 pg/mL)
  • Major surgery within 14 days prior to randomization
  • Treatment with antiepileptics within the last 5 years
  • Previously diagnosed HIV or acute hepatitis infection
  • Uncontrolled hypertension, defined as a diastolic blood pressure measurement >110mm Hg during the screening period
  • History of congestive heart failure (NYHA class III, IV)
  • Unstable angina pectoris, active cardiac disease, cardiac infarction during the last six months before screening
  • Evidence of acute infectious disease or serious active inflammatory disease within four weeks before screening (Visit -1) or during the screening/baseline period
  • Known allergy to one of the ingredients of the test or reference products or hypersensitivity to mammalian-derived products
  • Pregnancy, breastfeeding women or women not using adequate birth control measures
  • Patients who participate simultaneously in another clinical study or who have participated in a study in the month preceding the start of this study or previously randomized to this study (except studies with approved medications in an approved indication, with an approved dosing regimen including approved treatment combinations)
  • Suspicion of any non-compliance

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

Germany15 sites

  • Gemeinschaftspraxis Drs. Brudler, Heinrich, Bangerter

    Augsburg, 86150

  • Gemeinschaftspraxis mit Schwerpunkt Hämatologie und Internistische Onkologie

    Bad Soden, 65812

  • Poliklinik am Paritätischen Krankenhaus

    Berlin, 10365

  • Schwerpunktpraxis für Brustkrankheiten und Gynäkologische Onkologie

    Berlin, 10367

  • Oskar-Helene-Heim

    Berlin, 14195

  • Praxis Drs. Marschner, Zeiss, Kirste

    Freiburg im Breisgau, 79106

  • DRK-Krankenhaus

    Luckenwalde, 14943

  • Praxis für Onkologie

    Munich, 80637

  • Praxis Drs. Kowolik/Prechtl

    Munich, 81925

  • Klinikum Nürnberg, 5. Medizinische Klinik Haus 12, Zimmer Nr. 13

    Nuremberg, 90419

  • Gemeinschaftspraxis

    Stuttgart, 70173

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitätsklinikum Tübingen Medizinische Klinik 1

    Tübingen, 72076

  • Gemeinschaftspraxis für internistische Onkologie

    Velbert, 42551

  • Praxis für internistische Onkologie

    Weiden, 92637

Other trials in Germany

Romania4 sites

  • Oncologic Institute

    Cluj-Napoca, 400015

  • Country hospital Oradea

    Oradea, 410032

  • County Hospital Satu-Mare

    Satu Mare, 440192

  • Oncomed SRL Timisoara

    Timișoara, 300239

Other trials in Romania

About this study

Official title: Double-blind, Randomized, Multicenter, Clinical Phase III Study to Evaluate the Efficacy and Safety of HX575 for the Treatment of Chemotherapy Associated Anemia in Cancer Patients

This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged >18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current standard medical practice.

Read the detailed description

Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dose adjustments to 300 IU/kg body weight three times per week were to be done if hemoglobin (Hb) increased <1.0 g/dL or the reticulocyte count increased <40,000 /μl after 4 weeks or if Hb increased <2.0 g/dL after 8 weeks of treatment. The primary endpoint was the Hb response in the EPO HEXAL group during weeks 5-12 of the study defined as absolute increase in Hb value of 2.0 g/dL from the mean value of the screening/baseline period in the absence of red blood cell transfusion during the preceding 4 weeks. For that purpose, Hb levels were measured at the weekly study visits by a central laboratory. Further parameters of treatment efficacy, safety and tolerability were recorded.

Conditions
Anemia
Being tested
HX575, solution for injection (s.c.), ERYPO®, Janssen-Cilag, solution for injection (s.c.)
Keywords
Chemotherapy associated anemia in cancer patients
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HX575, solution for injection (s.c.)Drug

    Also called Binocrit, Erythropoeitin alfa Hexal, Abseamed

    1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin

  • ERYPO®, Janssen-Cilag, solution for injection (s.c.)Drug

    Also called Eprex

    1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa

Study groups in NCT00711958
Study groupRoleWhat they receive
HX575 epoetin alfa Hexal AGExperimentalHX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
Receives: Drug: HX575, solution for injection (s.c.)
ERYPO® Janssen-CilagActive comparatorERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week.
Receives: Drug: ERYPO®, Janssen-Cilag, solution for injection (s.c.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia

    Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.

    Measured: 5-12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2008 (estimated)
  2. Study startNov 2004
  3. Primary completionJul 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711958
Sponsor's protocol ID
2003-31-INJ-11
Status last verified
Aug 2017
First submitted
3 Jul 2008
Last updated
5 Sep 2017
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HX575, solution for injection (s.c.) and ERYPO®, Janssen-Cilag, solution for injection (s.c.) in people with Anemia, run by Sandoz at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia (time frame: 5-12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00711958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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