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

NCT00142103 | Completed Phase 1 DMC

• 2 other identifiers: B1211001CPG10101-003
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 13

Brief Summary

1. 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. 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

Conditions

Hepatitis, Chronic Active

Keywords

Hepatitis c virus; HCV; Liver

Outcome Measures

Primary Outcomes (1)

• Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG

  16wks

Secondary Outcomes (1)

• Serum HCV RNA concentrations: Serum HCV concentrations over time to baseline

  12wks

Study Arms (6)

CPG10101

EXPERIMENTAL

Drug: CPG10101

CPG10101 + pegylated interferon

EXPERIMENTAL

Drug: CPG10101

CPG10101 + ribavirin

EXPERIMENTAL

Drug: CPG10101

CPG10101 + pegylated interferon + ribavirin

EXPERIMENTAL

Drug: CPG10101

Pegylated inteferon + ribavirin

ACTIVE COMPARATOR

Drug: Control

CPG10101 + pegylated interferon + ribavirin (rollover)

EXPERIMENTAL

Drug: CPG10101

Interventions

CPG10101 DRUG

CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks

CPG10101

Control DRUG

Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks

Pegylated inteferon + ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (13)

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202-2689, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64131, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29425, United States

Location

Pfizer Investigational Site

Jackson, Tennessee, 38305-2071, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75208, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78215, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23249, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hepatitis, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: May 16, 2011

Record last verified: 2011-05

Locations

US (13)