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TerminatedNCT01821625SQUELCH-CUpdated Nov 13, 2019Results posted

Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

A Phase 2/3 interventional study of Eltrombopag in Thrombocytopenia and Hepatitis C, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by University of Texas Southwestern Medical Center · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Interferon use for hepatitis C plummeted, eliminating the need for study drug.
Phase
Phase 2/3
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thrombocytopenia
  • Hepatitis C

Keywords

  • Thrombocytopenia
  • Hepatitis
  • Platelets
  • Eltrombopag
  • Liver Disease
  • Antiviral Treatment
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 7 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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

Interventions

  • DrugEltrombopag

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

    Also known as: Promacta

06

What researchers measure

Primary outcomes

  1. Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.

    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.

    Time frame: Up to 56 weeks

07

Results

Posted Oct 22, 2019

Participant flow

Participant flow — Overall Study
MilestoneThrombocytopenic (Low Platelet) Patients
Started7
Completed1
Not completed6
Withdrew: Withdrawal by subject2
Withdrew: Lack of efficacy2
Withdrew: Adverse event1
Withdrew: Medical contraindication1

Outcome measures

PrimaryPercentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.

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.

Time frame:
Up to 56 weeks
Reported as:
Count of participants · Participants
Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.
ParticipantsThrombocytopenic (Low Platelet) Patients
Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.1

Adverse events

Collected over 24 months. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Thrombocytopenic (Low Platelet) Patients0/7 (0%)0/7 (0%)3/7 (42.9%)
Most frequent other events
Most frequent other events
EventThrombocytopenic (Low Platelet) Patients
Variceal hemorrhageGastrointestinal disorders1/7
Skin ulcerSkin and subcutaneous tissue disorders1/7
Flu like symptomsNervous system disorders1/7

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Thrombocytopenic (Low Platelet) Patients
<=18 years0
Between 18 and 65 years7
>=65 years0
Age, Continuous
Age, Continuous(years)Thrombocytopenic (Low Platelet) Patients
Median53 (52 to 54)
Sex: Female, Male
Sex: Female, Male(Participants)Thrombocytopenic (Low Platelet) Patients
Female5
Male2
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Thrombocytopenic (Low Platelet) Patients
Hispanic or Latino2
Not Hispanic or Latino5
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Thrombocytopenic (Low Platelet) Patients
United States7
08

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390-8887, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01821625
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 1, 2013
Start date
Apr 2013
Primary completion
Apr 2015
Completion
Apr 2016
Results posted
Oct 22, 2019
Last update
Nov 13, 2019

Study contacts

William M Lee, M.D.
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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