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Protease Inhibitor

Ribavirin, peginterferon, boceprevir for Chronic Hepatitis C

Phase 4
Waitlist Available
Led By Mitchell L Shiffman, MD
Research Sponsored by Liver Institute of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Study Summary

A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

Eligible Conditions
  • Chronic Hepatitis C
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients who achieve eRVR at treatment week 28
Secondary outcome measures
Tolerability of treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ribavirin, peginterferon, boceprevirExperimental Treatment3 Interventions
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peginterferon alfa-2b
FDA approved
Ribavirin
FDA approved
Boceprevir
FDA approved

Find a Location

Who is running the clinical trial?

Chronic Liver Disease FoundationOTHER
1 Previous Clinical Trials
197 Total Patients Enrolled
Liver Institute of VirginiaLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,063 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
2013. "A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01731301.
All > Autoimmune Hepatitis > Hepatitis C
~2 spots leftby Apr 2025
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