Suspended

SQUELCH-CStudy of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

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What is being tested

Eltrombopag

Drug
Who is being recruted

Blood-Borne Infections+13

+ Cytopenia

+ Blood Platelet Disorders

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: November 13, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01821625
Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: November 13, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsCytopeniaBlood Platelet DisordersCommunicable DiseasesDigestive System DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHepatitis, Viral, HumanInfectionsRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsHepatitisHepatitis CLiver DiseasesThrombocytopenia

Criteria

12 inclusion criteria required to participate
Ability to cover costs of ribavirin, interferon, and boceprevir will also be required
Cirrhotic patients will be included
Confirmed history of chronic hepatitis C
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
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12 exclusion criteria prevent from participating
A history of a platelet disorder
A history of chronic infection (i.e., HIV or HBV) or a previous organ transplantation
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UT Southwestern Medical Center

Dallas, United StatesOpen UT Southwestern Medical Center in Google Maps
SuspendedOne Study Center