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Sponsored by: |
Peregrine Pharmaceuticals |
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Information provided by: | Peregrine Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00503347 |
This trial is designed to assess the safety, tolerability, pharmacokinetics and viral kinetics after multiple infusions of bavituximab in patients co-infected with HCV and HIV.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C Virus HIV Infections |
Drug: bavituximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase Ib Open-Label, Escalating Repeat-Dose Trial of Bavituximab (Chimeric Anti-Phosphatidylserine Monoclonal Antibody) in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus |
Estimated Enrollment: | 24 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
0.3 mg/kg
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Drug: bavituximab
The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab. |
2: Experimental
1 mg/kg
|
Drug: bavituximab
The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab. |
3: Experimental
3 mg/kg
|
Drug: bavituximab
The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab. |
4: Experimental
6 mg/kg
|
Drug: bavituximab
The study drug is a sterile solution administered intravenously weekly for 8 weeks. Each cohort is given 0.3, 1, 3, or 6 mg/kg of bavituximab. |
OBJECTIVES:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A history of including central venous catheter-related thrombosis is acceptable if there is documentation of resolution at least 12 months prior to enrollment.
Contact: Dianne Uphoff, RN, CCRA | 714-508-6031 | duphoff@peregrineinc.com |
Contact: Jennifer Lai, MBA, CCRA | 714-508-6097 | jlai@peregrineinc.com |
United States, California | |
Orange Coast Medical Center | Recruiting |
Newport Beach, California, United States, 92663 | |
Contact: Rosie Magallon 949-646-1111 | |
Principal Investigator: Jorge Rodriguez, MD | |
United States, Maryland | |
Johns Hopkins University, Center for Viral Hepatitis | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Heather Thomas, RN, BSN 410-614-0452 | |
Principal Investigator: Mark S. Sulkowski, MD | |
United States, New Jersey | |
Saint Michael's Medical Center | Recruiting |
Newark, New Jersey, United States, 07102 | |
Contact: James Fallon 973-877-2663 | |
Principal Investigator: Stephen M Smith, MD | |
United States, Texas | |
Southwest Infectious Disease Associates | Recruiting |
Dallas, Texas, United States, 75204 | |
Contact: Denise Hayes 214-828-4702 ext 102 | |
Principal Investigator: Nicholaos C. Bellos, MD |
Principal Investigator: | Stephen M Smith, MD | Saint Michael's Medical Center |
Principal Investigator: | Mark S. Sulkowski, MD | Johns Hopkins University, Center for Viral Hepatitis |
Principal Investigator: | Jorge Rodriguez, MD | Orange Coast Medical Center |
Principal Investigator: | Nicholaos C. Bellos, MD | Southwest Infectious Disease Associates |
Responsible Party: | Peregrine Pharmaceuticals ( Dianne Uphoff/Senior Clinical Project Manager ) |
Study ID Numbers: | PPHM 0603 |
Study First Received: | July 16, 2007 |
Last Updated: | June 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00503347 History of Changes |
Health Authority: | United States: Food and Drug Administration |
coinfection with chronic hepatitis C virus and HIV Treatment Naive |
Sexually Transmitted Diseases, Viral Liver Diseases Hepatitis, Chronic Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Antibodies, Monoclonal Hepatitis Virus Diseases |
Antibodies Digestive System Diseases HIV Infections Sexually Transmitted Diseases Hepatitis C Hepatitis C, Chronic Retroviridae Infections Immunoglobulins |
Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Immune System Diseases Hepatitis, Chronic Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection |
Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Hepatitis C Hepatitis C, Chronic Retroviridae Infections |