Study of AVI-4065 in Healthy Volunteers and Chronic Active HCV Patients

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic active hepatitis C viral infections are difficult to treat: current drug therapies can result in severe side effects that some patients will not tolerate. AVI-4065 Injection is a new drug designed to prevent the virus from reproducing in the body. We tested this drug in healthy adult volunteers to optimize the dosing regimen, and are now proceeding in adult patients with chronic active hepatitis C infections. Patients who have the disease and who have had treatment but without success, will be recruited for the study.

The treatment of HCV patients initially consisted of subcutaneous injections given twice a day for 14-days. Treatment arms of 28 days, twice or three-times per day have been added.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarepta Therapeutics; Sarepta Therapeutics, Inc.

Criteria

Inclusion Criteria - Part II: (HCV Infected Patients)

• Adult males and females aged 18 to 64 years of age

• Chronic HCV infection, defined as virological diagnosis of HCV for at least six months with detectable serum HCV-RNA levels >100,000 IU/mL by an HCV-RNA PCR assay on two occasions at least one week apart within 4 weeks prior to study drug administration

• Signed and dated written informed consent form

• Negative serum ß-HCG (pregnancy) test 24 hours prior to initial dose of AVI-4065 Injection for females of childbearing potential, or post-menopausal and amenorrheic for 2 years, or surgically sterilized for at least one year

• Willing to abstain from alcohol from the beginning of study entry through Day 28 of the study

• Willing to participate in all study activities (including the ability to safely self-inject study drug subcutaneously) and all study requirements (including effective contraception) during study period

Exclusion Criteria - Part II (HCV Patients):

• Hematology, coagulation, serum chemistry, and urinalysis laboratory test values >2 times upper limits of normal or anemia (hemoglobulin <11 g/dL), leukopenia (total white blood count <3,000/ µL or total neutrophils <1,500/ µL) or thrombocytopenia (platelets <100,000/ µL)

• Decompensated or severe liver disease, defined as cirrhotic patients with a Child-Pugh score of ≥ 7

• Encephalopathy or altered mental status of any etiology

• Any neoplasm, including hepatocellular carcinoma

• Decompensated renal disease (e.g., serum creatinine >2.5 or on a dialysis program)

• Positive HIV-1 or HIV-2 serology

• Positive Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) status

• Participation in any interventional clinical trial within previous 6 months

• Organ transplant recipient (solid or hematopoietic)

• Use of interferons and ribavirin or experimental HCV treatment within past 6 months

• Use of non-steroidal anti-inflammatory agents (e.g., ibuprofen, naproxen or COX-2 inhibitors) that exceeds 2 days per week of the recommended daily dosing or usage that exceeds 5 grams/week.

• Use of acetaminophen within 15 days of enrollment and throughout Day 28 of the study

• Body Mass Index (BMI) > 35

• Pregnant or nursing female

• Active serious or poorly controlled chronic illness

• History of poor compliance with health and treatment regimens

• Use of herbal or homeopathic products, illicit drugs, statins, corticosteroids, immunosuppressives, or cytotoxic agents within 90 days of first dose of study drug

• Use of drugs with potential hepatotoxicity, e.g., oral antifungals or oral glucophage inhibitors

• Unwilling to participate in any study activity (including to safely self-inject study medication subcutaneously) and complete any study requirement (including effective contraception) during study period and competition of any study visit

• Investigator opinion of unsuitability