Status:
TERMINATED
Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Thrombocytopenia
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
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 ot...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01821625
Start Date
April 1 2013
End Date
April 1 2016
Last Update
November 13 2019
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-8887