CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects
NCT00142103
ABOUT THIS 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 < 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 within normal limits (per central laboratory)
- Serum creatinine < upper limit normal per central laboratory or calculated 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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects | |||
Official Title ICMJE | CPG10101 Combination Therapy For The Treatment Of Hepatitis C: A Phase 1b Open Label Randomized Trial Of CPG10101 Alone, With Interferon, Ribavirin, Or Interferon And Ribavirin In The Treatment Of Relapsed Hepatitis C Virus (HCV) Subjects | |||
Brief Summary |
| |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hepatitis, Chronic Active | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 91 | |||
Original Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | February 2007 | |||
Actual Primary Completion Date | February 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: 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 ?g weekly or > 1.0 ?g/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:
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: 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:
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. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00142103 | |||
Other Study ID Numbers ICMJE | B1211001 CPG10101-003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |