Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00210600|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: PROCRIT (Epoetin alfa)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||186 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2005|
|Actual Study Completion Date :||August 2006|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210600
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|