Chemotherapy Induced AnemiaPhase 3NCT00144495
A Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
A Phase 3 study testing recombinant human erythropoietin in people with Chemotherapy Induced Anemia, run by Chugai Pharmaceutical.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Chemotherapy Induced Anemia
- What is being tested?
- recombinant human erythropoietin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients
Who cannot join
- a history of myocardial, cerebral or pulmonary infarction
- severe hypertension beyond control by drugs
About this study
Official title: A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.
- Conditions
- Chemotherapy Induced Anemia
- Being tested
- recombinant human erythropoietin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human erythropoietinDrug
3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks
recombinant human erythropoietinDrug
36000IU(s.c.)/week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patient whose ΔHb is less than 1.0g/dL on the day of 7th administration Receives: Drug: recombinant human erythropoietin |
| 2 | Experimental | patient whose ΔHb is 1.0g/dL or above on the day of 7th administration Receives: Drug: recombinant human erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The increase in Hb concentration
Measured: Day 28th or later
Secondary outcomes (1)
Changes in QOL scores
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionNov 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yoshiharu Ishikura, Study director, Chugai Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144495
- Sponsor's protocol ID
- EPO308JP
- Status last verified
- Jan 2009
- First submitted
- 2 Sep 2005
- Last updated
- 2 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study of Recombinant Human Erythropoietin in Anemic Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT00144495
- Acronym / sponsor ID
- EPO308JP
- Conditions
- Chemotherapy Induced Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: recombinant human erythropoietinpatient whose ΔHb is less than 1.0g/dL on the day of 7th administration |
| 2 | Experimental | Drug: recombinant human erythropoietinpatient whose ΔHb is 1.0g/dL or above on the day of 7th administration |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cancer patients
Key exclusion criteria (2 listed)
- a history of myocardial, cerebral or pulmonary infarction
- severe hypertension beyond control by drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human erythropoietin3600IU(s.c.)/week for 7 weeks and 54000IU(s.c.)/week for 5 weeks | Drug | 1 |
| recombinant human erythropoietin36000IU(s.c.)/week for 12 weeks | Drug | 2 |
Primary outcome
The increase in Hb concentration
Time frame: Day 28th or later
1 secondary outcome
Changes in QOL scores
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiharu Ishikura study director
Chugai Pharmaceutical
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant human erythropoietin in people with Chemotherapy Induced Anemia, run by Chugai Pharmaceutical.
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 1 inclusion and 2 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 2 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The increase in Hb concentration (time frame: Day 28th or later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2009.