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| Sponsor: | Abraxis BioScience Inc. |
|---|---|
| Information provided by: | Abraxis BioScience Inc. |
| ClinicalTrials.gov Identifier: | NCT00249002 |
Purpose
This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemodialysis Graft Dysfunction |
Drug: ABI-007 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Phase II Trial Of ABI-007 (A Cremophor El-Free, Protein Stabilized, Nanoparticle Paclitaxel) For The Prevention Of Vascular Access Graft Failure In Patients Undergoing Hemodialysis |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2005 |
This is an open-label, pilot, phase II study to assess the feasibility of administering ABI-007 intravenously [IV] over 3-5 minutes to patients with hemodialysis graft dysfunction (i.e., either a thrombosed PTFE graft, or a patent but dysfunctional PTFE graft). Patients with graft dysfunction who are successfully treated with angioplasty will start treatment after angioplasty or during their first dialysis through the graft following intervention, and will receive 3 subsequent treatments of ABI-007 at 35 mg/m2 on weeks 5, 13 and 21.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Peoria, Illinois, United States | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States | |
| United States, New York | |
| Rochester, New York, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| Study Director: | Joes Iglesias, MD | Abraxis BioScience Inc. |
More Information
| Study ID Numbers: | HD001 |
| Study First Received: | November 3, 2005 |
| Last Updated: | February 2, 2010 |
| ClinicalTrials.gov Identifier: | NCT00249002 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Vascular Access Graft Failure Venous Neointimal Hyperplasia(VNH) Hemodialysis |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |