Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

Study ID
STU 032013-020

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern-Other

Jody Rule

Principal Investigator
William Lee, M.D.

Official Title

Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

Brief Overview

This study will provide chronic hepatitis C (CHC) 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 CHC 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.

Participant Eligibility

Inclusion Criteria:

- Male and female patients at least 18 years of age.

- Require a platelet count below 75 x 10^9 /L at time of screening.

- The patients must meet the eligibility criteria for all drugs involved.

- Only genotype 1 (a, b, indeterminate, or mixed).

- Confirmed history of chronic hepatitis C.

- Cirrhotic patients will be included.

- Liver imaging within 1 year to exclude hepatocellular carcinoma (HCC) is required in
patients with cirrhosis.

- Patients without evidence of cirrhosis but meeting platelet criteria will also be
admitted to study.

- Subjects must be able to provide informed consent, comply with drug administration
instructions, and be able to complete each study visit.

- Ability to cover costs of ribavirin, interferon, and boceprevir will also be

- Female subjects are eligible if: Non-pregnant, non-childbearing potential, or of
childbearing potential and willing to perform complete abstinence or correctly use a
form of birth control during intercourse [barrier method, intrauterine device,
hormonal therapy, or surgical sterilization in females or male partner]. They must
also be willing to have pregnancy tests performed every 4- weeks until 6 months after
completion of ribavirin.

- Male study participants must agree to use a condom and their female partner must
partake in one of the contraceptive methods discussed above until 6 months after
completion of ribavirin therapy.

Exclusion Criteria:

- A history of chronic infection (i.e., HIV or HBV) or a previous organ

- A history of a platelet disorder.

- A poorly controlled underlying medical illness (i.e., diabetes, hypertension,
coronary artery disease, congestive heart failure, etc.).

- Any contraindication to any study drugs as mentioned in their respective prescribing

- Patients with decompensated cirrhosis defined as current evidence for ascites,
encephalopathy, infection or variceal bleeding. All patients should be considered
Child-Pugh Class A.

- Patients with AST/ALT levels ≥ 500 IU/L will be excluded on presumption of another
active liver disease.

- Patients must not be pregnant or nursing.

- The study physician maintains the right to exclude a patient for a medical condition
not listed above or based off laboratory values indicating chronic disease discovered
at screening.

- Patients with eye disease may be excluded from this study if the ophthalmologist does
not recommend treatment.

- Subjects with known hypersensitivity reactions (such as Stevens-Johnson syndrome,
toxic, epidermal necrolysis, and erythema multiforme to ribavirin) to study drugs or
any component of the products.

- Subjects with autoimmune hepatitis, hemoglobinopathies (e.g., thalassemia major,
sickle-cell anemia), creatinine clearance less than 50 mL/min.

- Co-administration of drugs that are highly dependent on CYP3A4/5 for clearance and
CYP3A4/5 inducers (See Table 2 in boceprevir prescribing information).