This study will provide chronic hepatitis C patients with low platelets (less than 75x10\^9/L) the opportunity to undergo treatment and possible cure of their virus. The main hepatitis C drugs will be administered as standard of care, with the addition of the study drug eltrombopag. The investigators hypothesize that providing eltrombopag to chronic hepatitis C patients with low platelets (less than 75x10\^9/L) will permit the initiation and completion of antiviral triple therapy with boceprevir, ribavirin, and pegylated-interferon.
SQUELCH-C is an investigator-initiated, single arm, non-blinded pilot study on the use of eltrombopag in combination with ribavirin, pegylated-interferon, and boceprevir, for patients who would not otherwise be treatment candidates because of low platelet counts (less than 75x10\^9/L). Administration of the drugs ribavirin and boceprevir will be standard of care, with one exception for interferon. The total drug treatment period for the study patient will range from 32 - 56 weeks, depending on liver disease stage and viral response. Follow-up will take place at 12 and 24 weeks post treatment to evaluate for sustained viral response. Total study participation may require 1.5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
UT Southwestern Medical Center
Dallas, Texas, United States
Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.
The length of therapy will depend on several factors: 1. Study patient's liver disease status. 2. Study patient's antiviral response. 3. Study patient's tolerance to treatment. One patient completed therapy and experienced a sustained viral response. A minimum full course of treatment will be 30 weeks, with a maximum of 56 weeks of treatment.
Time frame: Up to 56 weeks
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