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Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection

NCT01001754 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2011-12-05

No results posted yet for this study

Summary

Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

PEG-rIL-29

Weekly SC injections in combination with ribavirin for up to 48 weeks

DRUG

Peginterferon alfa-2a

Weekly SC injections in combination with ribavirin for up to 48 weeks

DRUG

Ribavirin

Daily oral administration (400-600 mg BID)

Sponsors & Collaborators

Principal Investigators

  • Jan Hillson, MD · ZymoGenetics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-11-30
Completion
2012-05-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Italy
  • Poland
  • Puerto Rico
  • Romania
  • Spain

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 NCT01001754 on ClinicalTrials.gov