| Trial ID: | L0776 |
| Source ID: | NCT01731301
|
| Associated Drug: |
Ribavirin
|
| Title: |
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Hepatitis C|End Stage Renal Disease
|
| Interventions: |
DRUG: Ribavirin|DRUG: Peginterferon|DRUG: Boceprevir
|
| Outcome Measures: |
Primary: Percentage of patients who achieve eRVR at treatment week 28, The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28., 28 weeks | Secondary: Tolerability of treatment, A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR, 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: Liver Institute of Virginia | Collaborators: Merck Sharp & Dohme LLC|Chronic Liver Disease Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
20
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2015-01
|
| Results First Posted: |
|
| Last Update Posted: |
2012-11-22
|
| Locations: |
Liver Institute of Virginia, Richmond, Virginia, 23226, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01731301
|
