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Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic HepC Virus Genotype 1 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01273948
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : February 6, 2012
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals

Study Description
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Brief Summary:

This will be a randomized, open-label, active-control Phase II pilot trial of bavituximab combined with ribavirin for initial treatment of chronic HCV genotype 1 infection. Eligible patients with normal coagulation, hematological, and renal function will undergo a screening/washout period of up to 28 days, followed by randomization to receive weekly bavituximab or PEG-IFN alpha-2a therapy for 12 weeks, both with twice-daily ribavirin.

The primary endpoint of this study is the proportion of patients who show a greater than or equal to 2-log10 IU reduction in plasma HCV RNA level after 12 weeks of treatment (early virological response; EVR).

Secondary endpoints include the proportion of patients with an undetectable HCV RNA level after 12 weeks of treatment; the proportion of patients who show a reduction in HCV RNA level of greater than or equal to 2 log10 IU after 4 weeks of treatment, viral kinetics for individual patients over time, and comprehensive evaluation of the safety and tolerability of bavituximab infusion.


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Bavituximab Drug: Pegylated interferon (PEG-IFN) Phase 1 Phase 2

Detailed Description:
Primary Objective: The primary objective of this study is to assess the effect of 12 weeks of initial treatment with bavituximab versus PEG-IFN, each combined with ribavirin, on plasma HCV RNA level in patients with chronic HCV genotype 1 infection.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Active-Control Phase II Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic Hepatitis C Virus Genotype 1 Infection
Study Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bavituximab 3 mg/kg
Bavituximab 3 mg/kg given by intravenous (IV) infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks
 Drug: Bavituximab
  1. Bavituximab 3 mg/kg given by intravenous (IV) infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or
  2. Bavituximab 0.3 mg/kg given by IV infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or
Other Name: Bavituxmab
Experimental: Bavituximab 0.3 mg/kg
Bavituximab 0.3 mg/kg given by IV infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks
 Drug: Bavituximab
  1. Bavituximab 3 mg/kg given by intravenous (IV) infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or
  2. Bavituximab 0.3 mg/kg given by IV infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or
Other Name: Bavituxmab
Active Comparator: Pegylated interferon (PEG-IFN)
Pegylated interferon (PEG-IFN) alpha-2a 180 micrograms given by subcutaneous (SC) injection once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks
 Drug: Pegylated interferon (PEG-IFN)
Pegylated interferon (PEG-IFN) alpha-2a 180 micrograms given by subcutaneous (SC) injection once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal 75 kg) divided into twice-daily doses, for 12 weeks
Other Name: Pegasys


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in Hepatitis C Virus RNA [ Time Frame: 12 weeks ]
    The primary endpoint is the proportion of patients who show a greater or equal 2-log(10) IU reduction in HCV RNA level at Study Week 12 (early virological response, EVR).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between the ages of 18 and 65 years
  2. Chronic hepatitis C virus (HCV) genotype 1 infection
  3. HCV RNA level >10,000 IU/mL

  4. Chronic HCV infection, defined as:

    • Previous documentation of positive HCV serology (HCV antibody or RNA) at least 6 months (24 weeks) previously, or
    • Positive HCV serology (HCV antibody or RNA) with a prior remote (more than 6 months previously) risk factor for acquisition of HCV or
    • Historical biopsy consistent with chronic HCV infection

  5. No clinically significant abnormalities in hematology, coagulation, or chemistry variables:

    • Hemoglobin >12 g/dL for women; >13 g/dL for men
    • Total white cell count >3000/mm3 and absolute neutrophil count >1500/mm3
    • Platelets >100,000/mm3
    • Prothrombin time (PT) and/or international normalized ratio (INR) less than or equal to 1.2 times the local upper limit of normal (ULN)
    • Conjugated (direct) bilirubin less than or equal to 1.5 times the ULN
    • Serum creatinine within normal limits
    • Thyroid-stimulating hormone (TSH) and free thyroxine (T4) within normal limits
  6. Female patients: negative urine pregnancy test
  7. Ability to provide informed consent

Exclusion Criteria:

  1. Previous interferon-based antiviral therapy for chronic HCV infection
  2. Previous treatment with known immunogenic drugs
  3. Concomitant human immunodeficiency (HIV) or hepatitis B virus (HBV) infection
  4. Cause of liver disease other than chronic HCV infection, such as autoimmune or alcoholic liver disease
  5. Decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites
  6. Recipient of liver or other solid-organ transplantation
  7. Evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
  8. History of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia)
  9. History of thromboembolic events (eg, deep-vein thrombosis [DVT] or pulmonary embolism). Previous central venous catheter-related thrombosis is acceptable if there is resolution recorded at least 12 months before enrollment.
  10. Requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins)
  11. Condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids
  12. Investigational therapy within 28 days before the first planned dose of study drug
  13. Major surgery within 28 days before the first planned dose of study drug
  14. Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)
  15. Ongoing angina pectoris or other symptoms of coronary artery disease (CAD); history of stroke, or transient ischemic attack (TIA)
  16. History of suicidal ideation or attempt
  17. Condition requiring treatment (past or current) with coumarin-type agents
  18. Cardiac arrhythmia requiring medical therapy
  19. Serious nonhealing wound (including wound healing by secondary intention, ulcer, or bone fracture)
  20. Cancer, autoimmune disease, or any disease or concurrent therapy known to cause significant alteration in immune function (corticosteroids are allowed before study enrollment and during the study to treat an AE)
  21. Female patients and female partners of male patients: pregnancy, lactation, or inability/unwillingness to practice effective contraception
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01273948


Locations
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Georgia
LTD Vakhtang Bochorishvili Anticeptic Centre
Tbilisi, Georgia
Sponsors and Collaborators
Peregrine Pharmaceuticals
Investigators
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Study Chair: Janet Nuttall, MPH Peregrine Pharmaceuticals
More Information
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Responsible Party: Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01273948    
Other Study ID Numbers: PPHM 1003
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Bavituximab
Hepatitis C
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Immunological