Overview

Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

Status:
Terminated
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
GlaxoSmithKline
Criteria
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 required.

- 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 transplantation.

- 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
information.

- 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 aminotransferase 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).