MedTrace Logo

Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I

NCT00277758 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2008-03-07

No results posted yet for this study

Summary

This is a treatment study trial, in which we will assess the safety and tolerability of daily dose IL-2, as monotherapy for 12 weeks, followed by IL2 in combination with PEG-IFN and RBV for 48 weeks in the treatment of chronic Hepatitis C.

Conditions

  • Hepatitis C

Interventions

BIOLOGICAL

Interleukin 2

Interleukin-2 at 1.2 mU/M2 administered subcutaneously daily

DRUG

Ribavirin

Ribavirin @ 800 mg daily (\< 65 kg body weight), 1000 mg (65-85 kg), and 1200 mg (\> 85 kg)

BIOLOGICAL

Pegylated Interferon Alpha

Pegylated-Interferon-alpha 1.5 ug/kg weekly subcutaneously.

BIOLOGICAL

Inteleukin-2

Interleukin-2 administered as a daily subcutaneous injection at 1.2 mU/M2 BSA

DRUG

Ribavirin + Pegylated interferon-alpha

Pegylated interferon-alpha administered 1.5 ug/kg weekly. Ribivirin 800 mg daily for body weight \<65 kg, 1000 mg for body weight 65-85 kg, and 1200 mg for body weight \>85 kg.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Kendall A Smith, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2006-07-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00277758 on ClinicalTrials.gov