Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antiviral therapy · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Visual acuity (VA) is defined as acuteness or clearness of vision.
LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
| Arm | Type | Description |
|---|---|---|
| Open-label eltrombopag | EXPERIMENTAL | Open-label eltrombopag with dose titrations to support adequate platelet counts. |
| Name | Type | Description |
|---|---|---|
| Eltrombopag | DRUG | Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose. |
| Antiviral therapy | DRUG | Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion. |
Inclusion Criteria: * Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390 * Male or female ≥18 years old * Evidence of chronic HCV infection * While participating in TPL103922 or TPL108390, discontinued from study drug due to th...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
It is an investigational small molecule antiviral developed by GSK plc for hepatitis C. It was studied in a Phase 3 trial in patients with hepatitis C who had previously participated in eltrombopag studies. It is not described as an approved treatment.
GSK plc, which trades under the ticker GSK, is the developer of this investigational antiviral therapy for hepatitis C. The company sponsored the Phase 3 clinical trial that evaluated the therapy in patients with hepatitis C.
It has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The therapy is investigational and is not described as FDA approved.
One Phase 3 trial, NCT00996216, has been conducted. It was titled a clinical trial for non-responders who previously participated in eltrombopag studies TPL 103922 or TPL 108390. The trial enrolled 27 participants, was uncontrolled, and has been completed.
The Phase 3 trial NCT00996216 enrolled participants across the United States, Australia, Canada, France, Germany, Greece, Italy, Pakistan, and Spain. It enrolled 27 participants aged 18 years and older, including both sexes, and did not include healthy volunteers.