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

NCT00277238

Last updated date
Study Location
Pfizer Investigational Site
Chicago, Illinois, 60611, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatitis, Chronic Active
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 < 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
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.

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Hepatitis, Chronic ActiveCPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
NCT00277238
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  6. St. Louis, Missouri
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  8. Durham, North Carolina
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Advanced Information
Descriptive Information
Brief Title  ICMJE CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis, Chronic Active
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: April 21, 2011)
113
Original Enrollment  ICMJE
 (submitted: January 13, 2006)
90
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 NCT00277238
Other Study ID Numbers  ICMJE B1211002
CPG 10101-004
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP