Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

Hepatitis C Clinical Trial

— SQUELCH-C  

Official title:

Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01821625
• Other study ID #: STU 032013-020
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Thrombocytopenia

Intervention

Drug:
• Eltrombopag
Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.	The length of therapy will depend on several factors: Study patient's liver disease status.; Study patient's antiviral response.; 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.	Up to 56 weeks