Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Eltrombopag · 18 trials · 8 indications
Participants who achieved a platelet count \>=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported.
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.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.
Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.
The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment
Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.
Complete blood count, platelet count by blood draw
Following PK parameters will be assessed: Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC\[0-t\]), area under the curve (concentration/time) from time 0 extrapolated to infinity (AUC\[0 inf\]), maximum observed concentration (Cmax) and time to Cmax (tmax)
Plasma eltrombopag PK Parameters: area under the concentration time-curves from time zero to infinity AUC(0-infinity) and maximum concentration (Cmax).
Plasma boceprevir PK Parameters: AUC from time zero to the dosing interval AUC(0-τ), Cmax, and Concentraction at end of the dosing interval (Cτ)
Plasma eltrombopag PK Parameters: AUC(0-infinity) and Cmax
Plasma telaprevir PK Parameters: AUC(0-τ), Cmax, and Cτ.
plasma levels/protein binding for eltrombopag
| Arm | Type | Description |
|---|---|---|
| Eltrombopag plus standard of care | EXPERIMENTAL | Part 1, double-blind treatment group |
| Placebo plus standard of care | PLACEBO_COMPARATOR | Part 1, double-blind treatment group |
| Eltrombopag plus standard of care (Part 2 open-label) | EXPERIMENTAL | Part 2, open-label |
| Open-label eltrombopag | EXPERIMENTAL | Open-label eltrombopag with dose titrations to support adequate platelet counts. |
| Treatment | EXPERIMENTAL | Eltrombopag oral tablets once daily |
| eltrombopag | EXPERIMENTAL | active treatment arm |
| placebo | PLACEBO_COMPARATOR | placebo control arm |
| Treatment arm plus standard of care | EXPERIMENTAL | Subjects will initiate treatment with 50 mg eltrombopag or matching placebo once daily. Based upon the subjects platelet count at each visit, the dose of eltrombopag may be adjusted either up or down. |
| SEQUENCE D0, D1, D2 | EXPERIMENTAL | Participants will receive treatment D0 in treatment period 1, D1 in treatment period 2 and D2 in treatment period 3 (one treatment per period). Where D0=eltrombopag 50 milligram (mg), D1= cyclosporine 200 mg + eltrombopag 50 mg, and D2= cyclosporine 600 mg + eltrombopag 50 mg. Treatment periods will be separated by washout periods of 3-10 days |
| SEQUENCE D1, D0, D2 | EXPERIMENTAL | Participants will receive treatment D1 in treatment period 1, D0 in treatment period 2 and D2 in treatment period 3 (one treatment per period). Where D0=eltrombopag 50 mg, D1= cyclosporine 200 mg + eltrombopag 50 mg, and D2= cyclosporine 600 mg + eltrombopag 50 mg. Treatment periods will be separated by washout periods of 3-10 days |
| SEQUENCE D1, D2, D0 | EXPERIMENTAL | Participants will receive treatment D1 in treatment period 1, D2 in treatment period 2 and D0 in treatment period 3 (one treatment per period). Where D0=eltrombopag 50 mg, D1= cyclosporine 200 mg + eltrombopag 50 mg, and D2= cyclosporine 600 mg + eltrombopag 50 mg. Treatment periods will be separated by washout periods of 3-10 days |
| Eltrombopag 50 mg | EXPERIMENTAL | Each volunteer will receive orally, single dose of tablet eltrombopag 50 mg under fasting conditions |
| Boceprevir | EXPERIMENTAL | Subjects will receive boceprevir 800 mg orally every 8 hours (hrs) for 10 days in Period 2 with moderate-fat meals. |
| Telaprevir | EXPERIMENTAL | Subjects will receive telaprevir 750 mg orally every 8 hours hrs for 10 days in Period 2 with moderate-fat meals. |
| Eltrombopag and Broceprevir | EXPERIMENTAL | Subjects will receive eltrombopag 200 mg as single oral dose and boceprevir 800 mg orally every 8 hrs for a day in Period 3 with moderate-fat meals. |
| Eltrombopag and Telaprevir | EXPERIMENTAL | Subjects will receive eltrombopag 200 mg as single oral dose and telaprevir 750 mg orally every 8 hrs for a day in Period 3 with moderate-fat meals. |
| Arm B | EXPERIMENTAL | 25 mg powder for oral suspension single dose fasted. |
| Arm C | EXPERIMENTAL | 25 mg powder for oral suspension administered with a meal |
| Arm D | EXPERIMENTAL | 25 mg powder for oral suspension administered 2 hours prior to meal |
| Arm E | EXPERIMENTAL | 25 mg powder for oral suspension administered 2 hours after to meal |
| Arm A | OTHER | Commercially available eltrombopag 25 mg tablet |
| Period 2 | ACTIVE_COMPARATOR | Treatment B |
| Period 1 | ACTIVE_COMPARATOR | Treatment A |
| Period 3 | ACTIVE_COMPARATOR | Treatment C |
| Arm 1 | EXPERIMENTAL | Eltrombopag 75 mg QD x 6 days |
| Arm 2 | ACTIVE_COMPARATOR | Ciprofloxicin 500mg BID x 6 days |
| Arm 3 | PLACEBO_COMPARATOR | Placebo QD x 6 days |
| Group B | EXPERIMENTAL | Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide |
| Group A | EXPERIMENTAL | Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag. |
| Healthy subjects | ACTIVE_COMPARATOR | Subjects will receive a single 50 mg oral dose of eltrombopag. |
| Subjects with hepatic impairment | EXPERIMENTAL | Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag. |
| Name | Type | Description |
|---|---|---|
| Eltrombopag | DRUG | Thrombopoietin receptor agonist |
| Placebo | DRUG | Placebo with no active pharmaceutical ingredient |
| Antiviral therapy | DRUG | Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion. |
| Eltrombopag oral tablets | DRUG | Eltrombopag oral tablets once daily |
| Cyclosporine | DRUG | Soft gelatine capsule containing cyclosporine 100 mg for oral administration. Cyclosporine will be administered at the doses of 200 mg (2 x 100 mg capsules) or 600 mg (6 x 100 mg capsules) |
| Boceprevir | DRUG | Each capsule contains 200 mg of Boceprevir (Dose 800 mg) |
| Telaprevir | DRUG | Each tablet contains 375 mg of Telaprevir (Dose 750 mg) |
| Lopinavir/Ritonavir | DRUG | Lopinavir/Ritonavir 400/100 mg oral dose given twice a day for 14 days |
| Eltrombopag and Lopinavir/Ritonavir | DRUG | Elrombopag 100 mg single oral dose and Lopinavir/Ritonavir 400/100 mg oral dose given in the AM and PM |
| Ciprofloxacin | DRUG | Given 500mg BID x 6 days |
Inclusion Criteria: * Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 6 years old) * Patients must be between 1 year and \<18 years of age at Day 1 * Patients will have a confirmed diagnosis of chronic ITP fo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
Eltrombopag is a small molecule being studied for use in idiopathic thrombocytopenic purpura, a condition of low platelet counts, as well as in healthy subjects and in patients with liver cirrhosis. It has also been investigated in the context of hepatitis C. The drug is in clinical development and is not yet approved.
Eltrombopag is being developed by GSK plc, which trades under the ticker GSK. The company has conducted multiple clinical trials of the drug across various patient populations, including healthy volunteers and patients with hepatic impairment or hepatitis C.
Eltrombopag is in Phase 1 clinical development. A total of seven trials have been completed, with no active trials currently ongoing. The completed trials include Phase 1 studies in healthy subjects and patients with hepatic impairment, as well as a Phase 3 study in non-responders to earlier eltrombopag studies.
Eltrombopag has been studied in several completed clinical trials, including NCT00359463 in healthy subjects and volunteers with mild, moderate, or severe hepatic impairment, NCT00833378 a drug interaction study with lopinavir/ritonavir in healthy adults, NCT00996216 in non-responders to prior eltrombopag studies, and NCT02254434 a pharmacokinetic study in healthy volunteers under fasting conditions.
Eltrombopag is the drug name used across the clinical trials. No alternative names have been reported for this asset. It is a small molecule therapeutic being developed by GSK plc for conditions related to low platelet counts and liver disease.