Primary Immune Thrombocytopenia (ITP)Phase 4NCT04518475
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
A Phase 4 study testing eltrombopag combining rituximab and eltrombopag in people with Primary Immune Thrombocytopenia (ITP), run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- eltrombopag combining rituximab and eltrombopag
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2020to 10 Aug 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed written informed consent
- Age from 18 to 60 years old
- Diagnosed with ITP and have a platelet count of <30 ×10^9/L on Day 1 (or within 48 hours prior to dosing on Day 1).
- Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy.
- Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment.
- No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
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- No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)
- Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP.
- White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions:
- Hemoglobin: females and males 10.0 g/dl are eligible for inclusion,
- Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion
- The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%.
- Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.
- Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.
Who cannot join
- Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.
- Pregnant or lactating women;
- Subjects is currently receiving treatment with another study medication.
- Any laboratory or clinical evidence for HIV infection.
- Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
- History of platelet aggregation that prevents reliable measurement of platelet counts.
- Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin
Xiaofan Liu, +86 13752006059, liuxiaofan@ihcams.ac.cn
Lei Zhang
About this study
Official title: A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.
Read the detailed description
The primary objective of this study was to evaluate the efficacy and safety of eltrombopag combining rituximab treating previously treated ITP patients compared to eltrombopag. The secondary objective was to evaluate the efficacy of eltrombopag combining rituximab in ITP patients with positive autoantibody compared to eltrombopag .In addition, health-related quality of life (HRQoL) measure was assessed in all participants.
224 eligible subjects were randomized to either eltrombopag combining rituximab or eltrombopag treatment in 1:1 ratio. 112 enrolled patients are randomly picked up to take eltrombopag combining with rituximab at the indicated dose. 112 enrolled patients are randomly picked up to take eltrombopag at the indicated dose.
The initial dose of eltrombopag administration was an oral 75 mg once daily in all participants .The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24.
Subjects in eltrombopag combining rituximab treatment group received single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Being tested
- eltrombopag combining rituximab, eltrombopag
- Keywords
- immune thrombocytopenia, autoantibody, eltrombopag, rituximab
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopag combining rituximabDrug
Also called TPO-R agonist & anti-CD20 antibody
After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count >250×10^9/L, the eltrombopag will stop until the platelet count <30×10^9/L.
All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.
Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.
eltrombopagDrug
Also called TPO-R agonist
After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count >250×10^9/L, the eltrombopag will stop until the platelet count <30×10^9/L.
Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.
| Study group | Role | What they receive |
|---|---|---|
| efficacy of eltrombopag combining rituximab | Experimental | After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count >250×10^9/L, the eltrombopag will stop until the platelet count <30×10^9/L.
All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.
Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12. Receives: Drug: eltrombopag combining rituximab |
| efficacy of eltrombopag | Active comparator | After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count >250×10^9/L, the eltrombopag will stop until the platelet count <30×10^9/L.
Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12. Receives: Drug: eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Number of participants achieving a platelet count >=30×10^9/L and at least doubling of the baseline count at Week 4, Week 8, and Week 12 .
Measured: From the start of study treatment (Day 1) up to the end of week 12.
Secondary outcomes (9)
Drug efficacy
Number of participants achieving a platelet count >=30×10^9/L at week 4, week 8, and week 12 in ITP patients with positive autoantibody
Measured: From the start of study treatment (Day 1) up to the end of week 4, week 8 and week 12.
Long-term treatment response
Number of participants achieving a platelet count >=30×10^9/L at week 16, week 20, and week 24.
Measured: From the start of study treatment (Day 1) up to the end of week 16, week 20 and week 24
Time to Response
Time to response is defined as time from the start of treatment to the first time of achieving a platelet count >=30×10^9/L and at least doubling of the baseline count during the whole 24 weeks.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Duration of response
Total duration of time a participant had a platelet count >=30×10^9/L
Measured: From the start of study treatment (Day 1) up to the end of week 24.
Evaluation of effectiveness
Number of participants that reduced or discontinued baseline concomitant ITP medications during the whole 24 weeks.
Measured: From the start of study treatment (Day 1) up to the end of week 24.
Number of participants with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale.
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Measured: From the start of study treatment (Day 1) up to the end of week 24.
Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ)
In all participants ,use ITP-PAQ to assess the HRQoL before and after treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 24.
Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
In all participants ,use FACIT-F to assess the HRQoL before and after treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 24.
Number of Participants with side effects of the drugs
Side effects of the drugs included fever, headache, serum disease,hypotension, rashes, infection liver injury, hypokalaemia, etc.
Measured: From the start of study treatment (Day 1) up to the end of week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start10 Aug 2020
- Primary completion10 Feb 2029 (estimated)
- Study completion10 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, Henan Cancer Hospital, Tianjin Medical University Second Hospital, The First Affiliated Hospital of Xiamen University, Affiliated Hospital of Nantong University
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, M.D., Ph.D, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518475
- Sponsor's protocol ID
- IIT2020011
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No