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).