AnemiaPhase 2NCT00210600
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy
A Phase 2 study testing PROCRIT (Epoetin alfa) in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- PROCRIT (Epoetin alfa)
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Aug 2006
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin (Hb) value of >= 11.0 g/dL and <= 12.0 g/dL
- No blood transfusions in the 28 days prior to the start of Treatment Phase
- Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
- Iron transferrin saturation (TSAT) > 20% or if TSAT<20%, serum ferritin must be greater than 100 ng/mL.
Who cannot join
- No myeloid malignancy or known history of myelodysplasia
- No planned radiation during the study
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
- No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
- No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
- Has not received an experimental drug or device within the past 30 days
About this study
Official title: Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.
The purpose of this study is to evaluate the safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).
Read the detailed description
This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:
- Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) >= 11.0 g/dL to <= 12.0 g/dL and
- Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to < 11 g/dL or has a Hb <11.0 g/dL at study entry.
For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study. All eligible patients with hemoglobin < 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.
- Conditions
- Anemia
- Being tested
- PROCRIT (Epoetin alfa)
- Keywords
- Anemia, Hemoglobin level
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCRIT (Epoetin alfa)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.
Secondary outcomes (1)
The proportion of patients in the early intervention group for whom all hemoglobin values during the 16 week PROCRIT (Epoetin alfa) treatment were > 11.0 g/dL and < 13.0 g/dL.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210600
- Sponsor's protocol ID
- CR003196
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.
- ClinicalTrials.gov ID
- NCT00210600
- Acronym / sponsor ID
- CR003196
- Conditions
- Anemia
- Keywords
- Anemia, Hemoglobin level
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- May 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 21 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 safety and efficacy of PROCRIT (Epoetin alfa) when administered at 120,000 Units once every three weeks by comparing early dosing (Hb 11g/dL-12g/dL) vs. standard dosing (Hb< 11g/dL).
Detailed description
This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:
- Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) >= 11.0 g/dL to <= 12.0 g/dL and
- Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to < 11 g/dL or has a Hb <11.0 g/dL at study entry.
For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study. All eligible patients with hemoglobin < 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin (Hb) value of >= 11.0 g/dL and <= 12.0 g/dL
- No blood transfusions in the 28 days prior to the start of Treatment Phase
- Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
- Iron transferrin saturation (TSAT) > 20% or if TSAT<20%, serum ferritin must be greater than 100 ng/mL.
Key exclusion criteria (6 listed)
- No myeloid malignancy or known history of myelodysplasia
- No planned radiation during the study
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
- No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
- No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
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 |
|---|---|---|
| PROCRIT (Epoetin alfa) | Drug | – |
Primary outcome
The proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.
1 secondary outcome
The proportion of patients in the early intervention group for whom all hemoglobin values during the 16 week PROCRIT (Epoetin alfa) treatment were > 11.0 g/dL and < 13.0 g/dL.
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 10 Jun 2011.
- Assessment of Early and Standard Intervention with PROCRIT (Epoetin alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients with Cancer Receiving ChemotherapyLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PROCRIT (Epoetin alfa) in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 6 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 10 Jun 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.. 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 10 Jun 2011.