Trial Outcomes & Findings for A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia (NCT NCT04214951)
NCT ID: NCT04214951
Last Updated: 2020-10-20
Results Overview
The percentage of patients who have reached platelet count ≥ 50×10\^9/L at 6 weeks after switching.
Recruitment status
UNKNOWN
Target enrollment
100 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
Eltrombopag Group
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
Recombinant Human Thrombopoietin (Rh-TPO) Group
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
n=10 Participants
|
28 years
n=10 Participants
|
29 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 6 weeksThe percentage of patients who have reached platelet count ≥ 50×10\^9/L at 6 weeks after switching.
Outcome measures
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
|---|---|---|
|
Response Rate at 6 Weeks After Switching
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 weeksAdverse event/serious adverse event associated with study drugs during 6 weeks after switching
Outcome measures
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
|---|---|---|
|
Treatments Associated Adverse Events
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 6 weeksReasons of switching eltrombopag and rh-TPO will be recorded, including lack of efficacy, patient preference, side effects, platelet count fluctuation
Outcome measures
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
|---|---|---|
|
Reasons of Switching
platelet count fluctuation
|
2 Participants
|
0 Participants
|
|
Reasons of Switching
lack of efficacy
|
2 Participants
|
2 Participants
|
|
Reasons of Switching
patient preference
|
1 Participants
|
5 Participants
|
|
Reasons of Switching
side effects
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 weeksNumber of participants with bleeding events of the two groups during 6 weeks after switching
Outcome measures
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
|---|---|---|
|
Number of Participants With Bleeding Events
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 weeksThe time to achieve platelet count ≥ 50×10\^9/L after switching.
Outcome measures
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
|---|---|---|
|
TOR (Time to Response)
|
2 weeks
Interval 1.0 to 4.0
|
5 weeks
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: 6 weeksThe duration of achieving platelet count ≥ 50×10\^9/L after switching.
Outcome measures
| Measure |
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 Participants
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
Eltrombopag Group
n=10 Participants
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
|---|---|---|
|
DOR (Duration of Response)
|
4 weeks
Interval 1.0 to 5.0
|
3 weeks
Interval 1.0 to 5.0
|
Adverse Events
Eltrombopag Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Recombinant Human Thrombopoietin (Rh-TPO) Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eltrombopag Group
n=10 participants at risk
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10\^9/L.The efficacy, safety, and patient/physician preference will be assessed.
Eltrombopag: Patients will be given eltrombopag 50mg once daily for 6 weeks.
|
Recombinant Human Thrombopoietin (Rh-TPO) Group
n=10 participants at risk
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10\^9/L. The efficacy, safety, and patient/physician preference will be assessed.
Recombinant human thrombopoietin (rh-TPO): Patients will be given rh-TPO 300 U/kg once daily for 21 days.
|
|---|---|---|
|
Hepatobiliary disorders
Elevated liver enzymes
|
10.0%
1/10 • Number of events 1 • 6 weeks
|
0.00%
0/10 • 6 weeks
|
|
General disorders
fever
|
0.00%
0/10 • 6 weeks
|
10.0%
1/10 • Number of events 1 • 6 weeks
|
Additional Information
Dr. Xiaohui Zhang, Director of Clinical Trials
Peking University People's Hospital
Phone: 86-10-88324577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place