Primary Immune Thrombocytopenic PurpuraITPNCT04890041
TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years
A study testing TPO-RA in people with Primary Immune Thrombocytopenic Purpura, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment . Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenic Purpura
- What is being tested?
- TPO-RA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women greater than or equal to 14 years of age.
- Participants diagnosed with primary immune thrombocytopenia with two platelet counts of < 30x10^9/L or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
- Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count < 30×109/L after treatment, or platelet count increase less than twice the baseline value, or with bleeding)
- Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.
Who cannot join
- Patients diagnosed with secondary immune thrombocytopenia.
- A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
- Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
- Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
- Have used rituximab in the past 3 months;
- Splenectomy in recent 3 months;
- Those who are not considered suitable for this study by the researcher;
- Women who are pregnant or who intend to become pregnant in the near future are excluded.
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 & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Lei Zhang, MD, +862223909240, zhanglei1@ihcams.ac.cn
Lei Zhang, +82223909240, zhanglei1@ihcams.ac.cn
About this study
Official title: Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study
This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .
Read the detailed description
The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.
100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.
- Conditions
- Primary Immune Thrombocytopenic Purpura
- Being tested
- TPO-RA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPO-RADrug
Also called TPO-RAs
The subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10^9/L and 150×10^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10^9/L, the treatment was stopped. If the platelet count is more than 400×10^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 100 subjects will be enrolled with the indicated treatment dose of TPO-RA Receives: Drug: TPO-RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Percentage of participants whose platelet count achieving response (R) within 6weeks.
Measured: From the start of study treatment (Day 1) up to the end of week 6
Secondary outcomes (5)
Treatment response
Percentage of participants achieving a platelet count >=50×10^9/L at week 1,2,3,4,5and 6 of treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Treatment response
Percentage of participants achieving a platelet count >=100×10^9/L at week 1,2,3,4,5and 6 of treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Duration of response
Percentage of participants whose platelet count achieving persistence response (R) within 6weeks(defined as the proportion of subjects with a platelet count of ≥30×109/L for at least 4 weeks of the 6-week treatment period without remedial therapy).
Measured: From the start of study treatment (Day 1) up to the end of week 6
Concomitant medication
The percentage of patients with reduced concomitant medication, reduced bleeding and remedial treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 6
Adverse events
Incidence of adverse events.
Measured: From the start of study treatment (Day 1) up to the end of week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start30 May 2021
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890041
- Sponsor's protocol ID
- IIT2020033
- Acronym
- ITP
- Status last verified
- Oct 2024
- First submitted
- 12 May 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study
- ClinicalTrials.gov ID
- NCT04890041
- Acronym / sponsor ID
- ITP / IIT2020033
- Conditions
- Primary Immune Thrombocytopenic Purpura
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .
Detailed description
The primary objective of this study was to evaluate the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years who had not responded to first-line in the previous treatment.
100 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: TPO-RA100 subjects will be enrolled with the indicated treatment dose of TPO-RA |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women greater than or equal to 14 years of age.
- Participants diagnosed with primary immune thrombocytopenia with two platelet counts of < 30x10^9/L or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).
- Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U/kg/ day × 14-day rhTPO with no response to treatment (platelet count < 30×109/L after treatment, or platelet count increase less than twice the baseline value, or with bleeding)
- Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.
Key exclusion criteria (8 listed)
- Patients diagnosed with secondary immune thrombocytopenia.
- A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.
- Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);
- Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;
- Have used rituximab in the past 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPO-RAAlso: TPO-RAsThe subjects will receive an initial dose of TPO-RA once daily. Platelet counts were collected weekly until week 6 of the study. Dosage was adjusted to maintain platelet levels between 50×10^9/L and 150×10^9/L according to platelet count. TPO-RA was administered once a day for 4 weeks. If the platelet count dose not reach 30×10^9/L, the treatment was stopped. If the platelet count is more than 400×10^9/L after taking TPO-RA once a day for 2 consecutive weeks, the treatment will be stopped. | Drug | Treatment group |
Primary outcome
Treatment response
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Percentage of participants whose platelet count achieving response (R) within 6weeks.
5 secondary outcomes
Treatment response
Time frame: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Treatment response
Time frame: From the start of study treatment (Day 1) up to the end of week 1,2, 3, 4, 5 and 6.
Duration of response
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Concomitant medication
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Adverse events
Time frame: From the start of study treatment (Day 1) up to the end of week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Zhang principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TPO-RA in people with Primary Immune Thrombocytopenic Purpura, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Liu (+82223909240, liuwei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: From the start of study treatment (Day 1) up to the end of week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.