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Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease

NCT00028093 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-11-08

Study results available
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Summary

This study will examine the effectiveness of pegylated interferon, or peginterferon (a long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1) infection with and without kidney disease.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Peginterferon alfa-2a with Ribavirin

Eligible patients were given peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients \<75 kg and 1200 mg daily for patients \>=75 kg) for 48 weeks

DRUG

Peginterferon alfa-2a

Eligible patients were given peginterferon-alpha-2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Yaron Rotman, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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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 NCT00028093 on ClinicalTrials.gov