Phase 2B Dose Ranging Study of Locteron Plus Ribavirin to Treat HCV

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.

Key facts

Study ID

NCT00863239

Run by

Biolex Therapeutics, Inc.

People needed

116

Starts

2009-03-01

Expected to finish

2011-11-01

Last updated by the study team

2012-02-02

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects 18 through 69 years of age, inclusive
• Chronic hepatitis C genotype 1
• HCV ribonucleic acid (RNA) level > 10,000 IU/mL (by RT-PCR) at screening
• Creatine clearance ≥ 50 mL/min
• Neutrophil count > 1500 cells/mm3
• Platelet count > 90,000/mm3
• Hemoglobin > 12 g/dL for females and > 13 g/dL for males
• Female subjects of child-bearing potential agreeing to use dual methods for contraception
• Male subjects with female sexual partners agreeing to use effective birth control methods
• Negative serum pregnancy test for women of child-bearing potential • Compensated liver disease defined as INR < 1.5, conjugated bilirubin < 1.5 X ULN, serum albumin > 3.0 g/dL.

You may not qualify if…

• Prior antiviral treatment for hepatitis C
• Co-infection with HIV or hepatitis B virus
• Subjects with a body mass index (BMI) above 32 kg/m2
• Current or prior history of clinical hepatic decompensation
• Evidence of HCC
• Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening
• Known hypersensitivity to interferon alfa or ribavirin
• Chronic liver disease other than HCV not limited to HBV, hemochromatosis, auto-immune hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease)
• Clinically significant hemoglobinopathy such as thalassemia major and sickle cell anemia
• History of moderate, severe or uncontrolled psychiatric disease including depression and prior suicide attempts
• History of immune-mediated disease
• Significant renal or neurological disease
• Severe degree (> GOLD stage III) of chronic pulmonary disease (COPD) or active, severe asthma
• Subjects with severe cardiac disease (e.g., heart failure, recent [i.e., within 6 months prior to first dosing] myocardial infarction, angina, serious arrhythmias, including prolonged QTc [> 450 mSec], uncontrolled hypertension)
• History of significant central nervous system (including CNS trauma) or seizure disorders
• Cancer within the last 5 years, or previous cancer with a high risk of recurrence, including metastatic breast cancer; non-melanoma skin cancer is not an exclusion criterion
• History of solid organ or bone marrow transplantation
• Clinical or laboratory evidence of uncontrolled thyroid disease, e.g., by thyroid stimulating hormone (TSH) level > 1.2 X upper limit of normal
• Clinically significant retinopathy; this needs to have been excluded by an eye exam performed by an ophthalmologist within the last 6 months prior to screening for subjects with hypertension or diabetes mellitus
• Drug abuse or alcohol consumption within the last 6 months which, in the opinion of the investigator, may affect study participation or outcome. Subjects in a supervised methadone treatment program on a stable regimen for > 6 months may be considered
• Taken any experimental agent within 12 weeks prior to screening
• More than 30 days of systemic immunosuppressive medication to include steroids in doses equivalent to or greater than 10 mg prednisone per day within 30 days prior to screening (inhaled corticosteroids are allowed)
• Nursing mother or male partner of pregnant female.

Where it is running

• eStudy site — Chula Vista, California, United States
• eStudy Site — Oceanside, California, United States
• Medical Associates Research Group — San Diego, California, United States
• University of Louisville Health Care Outpatient Center — Louisville, Kentucky, United States
• Maryland Digestive Disease Research, LLC — Laurel, Maryland, United States
• St. Louis University — St Louis, Missouri, United States
• AGA Clinical Research Associates, LLC. — Egg Harbor, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Consultants for Clinical Research — Cincinnati, Ohio, United States
• The Liver Institute at Methodist Dallas — Dallas, Texas, United States
• Alamo Medical Center — San Antonio, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• McGuire DVAMC — Richmond, Virginia, United States
• Tokuda Hospital — Sofia, Bulgaria
• UMHAT "Alexandrovska" — Sofia, Bulgaria
• UMHAT "St Ivan Rilski" — Sofia, Bulgaria
• UMHAT "Queen Giovanna - ISUL" EAD — Sofia, Bulgaria
• Medical Institute Ministry of Interior — Sofia, Bulgaria
• Military Medical Academy — Sofia, Bulgaria
• UMHAT "St Marina" — Varna, Bulgaria
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico
• Institute of Infectious Diseases — Bucharest, Romania
• Fundeni Clinical Institute — Bucharest, Romania
• "Victor Babes" Clinical Hospital Craiova — Craiova, Romania

Full record on ClinicalTrials.gov

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