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

NCT00142103

Last updated date
Study Location
Pfizer Investigational Site
Miami, Florida, 33136, 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 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.

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


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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  8. Hershey, Pennsylvania
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  3. New Orleans, Louisiana
  4. Detroit, Michigan
  5. Kansas City, Missouri
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  7. New York, New York
  8. Durham, North Carolina
  9. Cleveland, Ohio
  10. Hershey, Pennsylvania
  11. Germantown, Tennessee
  12. Dallas, Texas
  13. San Antonio, Texas
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Advanced Information
Descriptive Information
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
  1. To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin when administered weekly for twelve weeks in relapsed HCV positive subjects.
  2. To assess the effect of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin on serum Hepatitis C Virus (HCV) RNA concentrations
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
  • Drug: CPG10101
    CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks
  • Drug: CPG10101
    CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks
  • Drug: CPG10101
    CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Ribavirin, oral, 800-1400mg, daily, 12wks
  • Drug: CPG10101
    CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
  • Drug: Control
    Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
Study Arms  ICMJE
  • Experimental: CPG10101
    Intervention: Drug: CPG10101
  • Experimental: CPG10101 + pegylated interferon
    Intervention: Drug: CPG10101
  • Experimental: CPG10101 + ribavirin
    Intervention: Drug: CPG10101
  • Experimental: CPG10101 + pegylated interferon + ribavirin
    Intervention: Drug: CPG10101
  • Active Comparator: Pegylated inteferon + 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: May 13, 2011)
91
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
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:

  • 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.

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:

  • 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.

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 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
Study Director:Pfizer CT.gov Call CenterPfizer
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