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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

NCT00277238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2017-03-08

No results posted yet for this study

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.

Conditions

  • Hepatitis, Chronic Active

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277238 on ClinicalTrials.gov