Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C (SQUELCH-C)

October 30, 2019 updated by: University of Texas Southwestern Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-8887
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thrombocytopenic (Low Platelet) Patients

All study patients will undergo intervention in this study.

The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).
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.
Other Names:
  • Promacta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.
Time Frame: Up to 56 weeks

The length of therapy will depend on several factors:

  1. Study patient's liver disease status.
  2. Study patient's antiviral response.
  3. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: William M Lee, M.D., UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 23, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

April 1, 2013

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 032013-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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