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CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects | Clinical Trials | Clareo Health

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CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

CPG 10101 Combination Therapy for the Treatment of Hepatitis C: A Phase II Randomized, Open Label, Multi-Center, Parallel Arm, Controlled Trial of CPG 10101 at Two Different Dose Levels With Pegylated-Interferon-Alpha 2B (PEG-IFN) Plus Ribavirin (RBV) or PEG-IFN Plus RBV Without CPG 10101 in the Treatment of Non-Responder (Null and Partial Responder) HCV Genotype 1 Infected Subjects

NCT00277238•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy and tolerability of CPG 10101 at two different dose levels with pegylated-interferon-alpha 2B (PEG-IFN) plus ribavirin (RBV) compared to PEG-IFN and RBV without CPG 10101 in HCV positive subjects who were classified as non-responders to previous adequate PEG-IFN plus RBV therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•HCV positive subjects documented by serum HCV RNA concentration \> 100,000 IU/mL within 21 days of first study treatment Receipt of adequate previous PEG-IFN and RBV therapy for a minimum of 12 weeks (PEG-IFN alpha-2a doses of \> 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) not resulting in a minimum of a 2 log decrease in HCV RNA concentrations while on treatment (null responders). Or, receipt of adequate previous treatment PEG-IFN and RBV therapy for a minimum of 24 weeks (PEG-IFN alpha-2a doses of ≥ 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) resulting in a minimum of a 2 log decrease in serum HCV RNA concentrations by 12 weeks of treatment but not resulting in an undetectable viral load after 24 weeks of treatment (partial responders). If dose modifications were necessary during the treatment due to adverse events, the subject must have received at least 80% of the PEG-IFN dose and 80% of the RBV dose to be eligible for the study.
•HCV genotype 1 only; other HCV genotypes are excluded. Adults, 18+ years old Written informed consent Liver biopsy within 5 years of the first dose of study drug, documenting changes consistent with hepatitis C
•Adequate bone marrow, liver, and renal function demonstrated by:
•Hemoglobin \> 12 g/dL for females and \> 13 g/dL for males
•White blood cell (WBC) \> 3,000/mm3
•Neutrophils \> 1,500/mm3
•Platelets \> 80,000/mm3
•Total bilirubin \< 1.6 mg/dL
•Direct bilirubin \< 1.5 upper limit of normal. If indirect bilirubin is elevated, Gilbert's disease must be documented in chart and substantiated.
•Albumin \> 3.7 g/dL and \< 4.9 g/dL
+3 more criteria

Exclusion Criteria

•Treatment with any IFN based therapies and/or antiviral therapies within 30 days of the first dose of study drug Subjects who have previously received an HCV vaccine Child-Pugh Class B or C History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Subjects with mild to moderate depression in the past who have a normal to mild Beck Depression Inventory score and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment.
•Significant cardiovascular disease (e.g., New York Heart Association \[NYHA\] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias) History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogeneic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
•Other serious medical conditions including, but not limited to:
•HIV-1
•Hepatitis B (positive hepatitis B surface antigen \[HBsAg\])
•Cancer (active tumors in the last 5 years)
•Pregnant, partners of pregnant women, or nursing women
•Alcohol or drug misuse within 90 days of screening Use of immunosuppressive doses of steroids or any anti-metabolite therapies within 3 months of entry into the study (inhaled and topical corticosteroids are permitted).
•Receipt of any vaccine or immunoglobulin within 30 days before the first dose of study drug. Flu vaccines are only allowed once the subjects are qualified for 36 additional weeks of treatment.
•Prior administration of oligodeoxynucleotides (including study medication CPG 10101), ribozymes, or any known allergy to CPG 10101, interferon, RVN or their excipients.
+2 more criteria

Locations (14)

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Indianapolis, Indiana, United States

Pfizer Investigational Site

New Orleans, Louisiana, United States

Pfizer Investigational Site

Detroit, Michigan, United States

Pfizer Investigational Site

Kansas City, Missouri, United States

Pfizer Investigational Site

St Louis, Missouri, United States

Pfizer Investigational Site

New York, New York, United States

Pfizer Investigational Site

Durham, North Carolina, United States

Pfizer Investigational Site

Cleveland, Ohio, United States

Pfizer Investigational Site

Hershey, Pennsylvania, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

March 8, 2017

Enrollment

113

ACTUAL participants

Conditions

Hepatitis, Chronic Active

Interventions

CPG10101

DRUG

CPG10101

DRUG

Control

DRUG

CPG10101

DRUG