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CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33136 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Active Hepatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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HCV positive subjects documented by serum HCV RNA concentration greater than 1000 IU/mL
within 21 days of first study treatment.

Receipt of adequate pegylated IFN plus RVN based therapy for a minimum of 24 weeks
(pegylated interferon doses of > 180 μg weekly or > 1.0 μg/kg pegylated interferon weekly
and at least 800 mg RVN daily) resulting in undetectable HCV RNA concentrations while on
treatment with subsequent relapse (HCV RNA concentration detected) within six months of
stopping therapy.

HCV genotype 1. Adults, 18 + years old. Written Informed Consent. Liver biopsy documenting
changes of Hepatitis C within 5 years of the first dose of study drug.

Adequate bone marrow, liver, and renal function demonstrated by:

- hemoglobin > 12 g/dL for females and > 13 g/dL for males

- WBC > 3,000/mm3

- Neutrophils > 1,500/mm3

- Platelets > 80,000/mm3

- Total bilirubin

- Direct bilirubin Gilbert's disease must be documented in chart and substantiated.

- Albumin within normal limits (per central laboratory)

- Serum creatinine clearance > 100 mL/min (by Cockroft-Gault formula).

Negative pregnancy test in women of child bearing potential Females of childbearing
potential and males who have partners of childbearing potential must use two forms of
effective contraception during treatment and during the 6 months after treatment has been
concluded.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Treatment with IFN based therapies and/or antiviral therapies within 90 days of the first
dose of study drug.

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., NYHA class 3 congestive heart failure; myocardial
infarction within the past 6 months; unstable angina; coronary angioplasty within the past
6 months; uncontrolled atrial or ventricular cardiac arrhythmias).

History of immunodeficiency, autoimmune disease, 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, autoimmune thrombocytopenia.

Other serious medical conditions including, but not limited to:

- HIV-1,

- Hepatitis B (positive HBsAg),

- Cancer,

- Pregnant, partners of pregnant women, or nursing women, and/or

- Alcohol or drug misuse within 90 days of screening Use of immunosuppressive doses of
steroids or any antimetabolite 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
Prior administration of oligodeoxynucleotides (including study medication CPG 10101),
ribozymes, or any known allergy to CPG 10101, interferon, ribavirin or their excipients
Receipt of any investigational drug therapy within 30 days before the first dose of study
drug Any other condition that, in the opinion of the Investigator, may compromise the
safety or compliance of the subject or would preclude the subject from successful
completion of the study.

NCT00142103
Pfizer
Completed
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects

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[email protected]

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