Status:
TERMINATED
Study of AVI-4065 in Healthy Volunteers and Chronic Active HCV Patients
Lead Sponsor:
Sarepta Therapeutics, Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief 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 desi...
Detailed Description
Hepatitis C virus (HCV) is the most common blood-borne infection in the United States and a worldwide public health problem of epidemic proportions. Benign in the acute phase of infection, HCV infecti...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00229749
Start Date
September 1 2005
End Date
January 1 2007
Last Update
April 10 2008
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