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History of Changes for Study: NCT01273948
A Randomized, Active-Control Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic Hepatitis C Virus Genotype 1 Infection
Latest version (submitted February 2, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 10, 2011 None (earliest Version on record)
2 February 4, 2011 Contacts/Locations, Study Status, Sponsor/Collaborators and Study Identification
3 August 5, 2011 Study Status
4 November 18, 2011 Recruitment Status, Study Status and Contacts/Locations
5 February 2, 2012 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations, Study Design and Study Identification
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Study NCT01273948
Submitted Date:  January 10, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: PPHM1003
Brief Title: A Randomized, Active-Control Pilot Trial of Bavituximab Combined With Ribavirin for Initial Treatment of Chronic Hepatitis C Virus Genotype 1 Infection
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2011
Overall Status: Recruiting
Study Start: January 2011
Primary Completion: January 2012 [Anticipated]
Study Completion: January 2012 [Anticipated]
First Submitted: January 7, 2011
First Submitted that
Met QC Criteria:
January 10, 2011
First Posted: January 11, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 10, 2011
Last Update Posted: January 11, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Peregrine Pharmaceuticals
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

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.
Open or close this module Conditions
Conditions: Hepatitis C
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 66 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • 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 Names:
  • Pegasys
Open or close this module Outcome Measures
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).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Janet Nuttall
Telephone: 760-438-1722
Email: jnuttall@peregrineinc.com
Central Contact Backup: A.J. Leyco
Telephone: 714-508-6026
Email: aleyco@peregrineinc.com
Locations: Georgia
LTD Vakhtang Bochorishvili Anticeptic Centre
[Recruiting]
Tbilisi, Georgia
Contact:Contact: Manana Makhviladze, MD +99532399013
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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