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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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chicago, Illinois, 60611 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.
Show details

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

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

- Albumin > 3.7 g/dL and

- Serum creatinine is > upper limit of normal then calculated creatinine clearance has to be > 100 mL/min
(by Cockcroft-Gault formula) for patient to be eligible.

Negative pregnancy test in women of childbearing 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.

Serum thyroid stimulating hormone (TSH) levels within normal ranges within 21 days of first
study treatment, regardless of treatment with L-thyroxin.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

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.

NCT00277238
Pfizer
Completed
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis, Chronic Active
  • Drug: CPG10101
    CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
  • Drug: CPG10101
    CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks
  • Drug: Control
    Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks
  • Experimental: CPG10101 (0.2) + pegylated inteferon + ribavirin
    Intervention: Drug: CPG10101
  • Experimental: CPG10101 (0.5) + pegylated inteferon + ribavirin
    Intervention: Drug: CPG10101
  • Active Comparator: Pegylated interferon + ribavirin
    Intervention: Drug: Control
  • Experimental: CPG10101 + pegylated interferon + ribavirin (rollover)
    Intervention: Drug: CPG10101
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
July 2007
July 2007   (Final data collection date for primary outcome measure)

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 ?g/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 ?g/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
  • Serum creatinine < upper limit of normal per central laboratory. If serum creatinine is > upper limit of normal then calculated creatinine clearance has to be > 100 mL/min (by Cockcroft-Gault formula) for patient to be eligible.

Negative pregnancy test in women of childbearing 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.

Serum thyroid stimulating hormone (TSH) levels within normal ranges within 21 days of first study treatment, regardless of treatment with L-thyroxin.

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.

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00277238
B1211002
CPG 10101-004
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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