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Protease Inhibitor
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis. 2. 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. 3. 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
- Kidney Failure
- Chronic Hepatitis C
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of patients who achieve eRVR at treatment week 28
Secondary study objectives
Tolerability of treatment
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
4,032 Previous Clinical Trials
5,189,696 Total Patients Enrolled
Mitchell L Shiffman, MDPrincipal InvestigatorLiver Institute of Virginia, Bon Secours Health System
1 Previous Clinical Trials
112 Total Patients Enrolled