Study of XTL6865 in Patients With Chronic Hepatitis C Virus Infection

NCT00300807 | Unknown Phase 1

• 2 other identifiers: XTL2005-16XTL6865
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 5

Brief Summary

1. 1.Evaluate the safety, tolerability, and virologic activity of escalating single (and multiple) doses of XTL6865, a mixture (1:1) of two human monoclonal antibodies (HCV-AbXTL68 and HCV-AbXTL65), in patients with chronic hepatitis C virus infection.
2. 2.Assess the pharmacokinetics of XTL6865 in the presence and absence of viral infection.

Conditions

Hepatitis C

Keywords

Hepatitis C; Monoclonal Antibody; failed IFN/RBV treatment

Outcome Measures

Primary Outcomes (2)

• log change in serum concentrations of HCV RNA

• change in serum anti-E2 concentrations

Interventions

XTL 6865 DRUG

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 patients between 18 and 65 years of age;
• female patients must be either postmenopausal, surgically sterile, or non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the study. Female patients of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control during the entire duration of the study. Male patients may be either surgically sterile, abstinent, or utilizing a barrier contraceptive method. Abstinence or contraceptive regimen must be maintained during screening, the treatment period and for 6 weeks following the XTL6865 dose;
• patient has been persistently HCV RNA-positive and remains HCV RNA-positive at screening (patient must have HCV RNA-concentrations which are at least 2 logs above the assay cut-off of 600 IU/mL) and HCV antibody (anti-HCV) positive;
• patient is negative for human immunodeficiency virus (HIV), hepatitis delta virus (HDV), and has no evidence of chronic hepatitis B virus (HBV) infection (assessed by Hepatitis B surface antigen or HBV DNA in blood within 3 months of Day 1 of the study) or other clinical signs, symptoms, or laboratory abnormalities (e.g. amino transferases) leading to the a diagnosis of current acute Hepatitis B disease;
• patient is in reasonably good health, as determined by the Investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests, except for findings related to their hepatitis C positive status.
• subject's private physician has been informed of the subject's planned participation in the study;
• capable of understanding and complying with the protocol, willing to reside in the study unit during the study period and to cooperate fully with the Investigator and site personnel, and must have signed the informed consent document prior to performance of any study-related procedures;
• infected with HCV genotype 1
• failed previous treatment for HCV infection with an approved regimen of IFN/RBV or pegylated IFN/RBV. Treatment failure includes both non-response (defined as a patient who did not experience a \> 2 log decrease in HCV RNA after 12 weeks of treatment or who failed to clear virus to below the limits of detection after 24 weeks of treatment) or relapse (defined as re-emergence of detectable concentrations of HCV RNA after response to treatment). Treatment must have been discontinued at least 3 months prior to Day 1 of the study.

You may not qualify if:

• liver transplant patients;
• patients with diabetes and HbA1c at screening of 7% or more;
• patients who have previously received HCV-AbXTL68;
• women who are pregnant, lactating, or have a positive serum pregnancy test at screening or positive urine pregnancy test on Day 1 at check-in;
• patient has hemoglobin \< 11 g/dL for women and 12 g/dL for men, platelet count \< 50,000 cells/mm3, bilirubin \> 3 mg/dL, serum creatinine \> 1.5 x normal, INR \>1.5 x normal, ALT \> 5 x upper limit of normal, or serum albumin \< 3.0 g/dL (at screening);
• patient has a history or evidence of advanced or decompensated liver disease, ascites, encephalopathy, bleeding esophageal varices, hematuria or proteinuria, alcohol or intravenous drug abuse (within \<= 1 years), fulminant liver failure, acute hepatitis from any source, periarteritis nodosa, serum sickness, an acute infectious illness, severe psychiatric disorder (including major depression), organic brain disorder, mental retardation, or other clinical conditions or diseases which in the judgment of the Investigator would interfere with the study or confound the results;
• patient has present active malignancy (except for superficial cancers)
• past history of pulmonary embolus, deep vein thrombosis, or current therapy with heparin or warfarin;
• patient has a history of pulmonary hypertension;
• patient with hypertension that is not, in the investigator's opinion, adequately controlled by medication (DBP \> 90 and SBP \> 140). In order to assess PK in the fasted state, patients should be able to delay administration of prescribed anti-hypertensive medicine for several hours without anticipating undue risk of medically significant increases in blood pressure. Patient should be on a stable anti-hypertensive regime for at least 30 days prior to screening with no changes in anti-hypertensive medications.
• patient is currently receiving antiviral therapy for HCV;
• patient has received IFN/RBV or pegylated IFN/RBV treatment within 3 months of study entry (Day 1);
• immunomodulatory therapy (eg, systemic corticosteroids or interferon) within 3 months of study entry (Day 1);
• any patient who does not meet the conditions for prior and concomitant treatments described in Section 6.6 of this protocol;
• any patient considering or scheduled to undergo any surgical procedure during the study;

Sponsors & Collaborators

• XTL Biopharmaceuticals: lead

Study Sites (5)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Mt Sinai School of Medicine

New York, New York, 10029, United States

Location

University Of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

Hadassah University Hospital

Jerusalem, Israel

Location

MeSH Terms

Conditions

Hepatitis C

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

• John Andrews, PhD

  XTL Biopharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 9, 2006
• Study Start: October 1, 2005
• Study Completion: April 1, 2007
• Last Updated: March 7, 2007

Record last verified: 2007-03

Locations

IL (1); US (4)