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

NCT01273948 | Completed Phase 1

• 1 other identifier: PPHM 1003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Reduction in Hepatitis C Virus RNA

  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).

  12 weeks

Study Arms (3)

Bavituximab 3 mg/kg

EXPERIMENTAL

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

Bavituximab 0.3 mg/kg

EXPERIMENTAL

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

Pegylated interferon (PEG-IFN)

ACTIVE COMPARATOR

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)

Interventions

Bavituximab DRUG

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

Also known as: Bavituxmab

Bavituximab 0.3 mg/kg; Bavituximab 3 mg/kg

Pegylated interferon (PEG-IFN) DRUG

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

Also known as: Pegasys

Pegylated interferon (PEG-IFN)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous interferon-based antiviral therapy for chronic HCV infection
• Previous treatment with known immunogenic drugs
• Concomitant human immunodeficiency (HIV) or hepatitis B virus (HBV) infection
• Cause of liver disease other than chronic HCV infection, such as autoimmune or alcoholic liver disease
• Decompensated clinical liver disease, including a history of encephalopathy, bleeding esophageal or gastric varices, or ascites
• Recipient of liver or other solid-organ transplantation
• Evidence of clinically significant bleeding, defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
• History of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia)
• 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.
• Requirement for concurrent treatment with oral or parenteral anticoagulants or hormones (estrogen-containing contraceptives, hormone replacement, antiestrogen agents, progestins)
• Condition requiring daily therapy with antiplatelet agents (eg, thienopyridines, dipyridamole, cilostazol; cardiovascular prophylaxis with aspirin is allowed) or corticosteroids
• Investigational therapy within 28 days before the first planned dose of study drug
• Major surgery within 28 days before the first planned dose of study drug
• Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease)
• Ongoing angina pectoris or other symptoms of coronary artery disease (CAD); history of stroke, or transient ischemic attack (TIA)

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (1)

LTD Vakhtang Bochorishvili Anticeptic Centre

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

bavituximab; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Janet Nuttall, MPH

  Peregrine Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 11, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

GE (1)