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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00142103
First received: August 31, 2005
Last updated: May 13, 2011
Last verified: May 2011
  Purpose
  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

Condition Intervention Phase
Hepatitis, Chronic Active
Drug: CPG10101
Drug: Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG [ Time Frame: 16wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum HCV RNA concentrations: Serum HCV concentrations over time to baseline [ Time Frame: 12wks ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: September 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPG10101 Drug: CPG10101
CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks
Experimental: CPG10101 + pegylated interferon Drug: CPG10101
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks
Experimental: CPG10101 + ribavirin Drug: CPG10101
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Ribavirin, oral, 800-1400mg, daily, 12wks
Experimental: CPG10101 + pegylated interferon + ribavirin 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
Active Comparator: Pegylated inteferon + ribavirin Drug: Control
Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
Experimental: CPG10101 + pegylated interferon + ribavirin (rollover) 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142103

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202-2689
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64131
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Pfizer Investigational Site
Jackson, Tennessee, United States, 38305-2071
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75208
Pfizer Investigational Site
San Antonio, Texas, United States, 78215
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00142103     History of Changes
Other Study ID Numbers: B1211001, CPG10101-003
Study First Received: August 31, 2005
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hepatitis c virus
HCV
Liver

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014