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
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.
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.
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 →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.
Exclusion Criteria:
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.
Also known as: Promacta
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
| Milestone | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| Started | 7 |
| Completed | 1 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Medical contraindication | 1 |
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.
| Participants | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines. | 1 |
Collected over 24 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Thrombocytopenic (Low Platelet) Patients | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| Event | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| Variceal hemorrhageGastrointestinal disorders | 1/7 |
| Skin ulcerSkin and subcutaneous tissue disorders | 1/7 |
| Flu like symptomsNervous system disorders | 1/7 |
| Age, Categorical(Participants) | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Age, Continuous(years) | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| Median | 53 (52 to 54) |
| Sex: Female, Male(Participants) | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| Female | 5 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Thrombocytopenic (Low Platelet) Patients |
|---|---|
| United States | 7 |
This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center