Immune ThrombocytopeniaPhase 3NCT05328804
Herombopag + rhTPO in Severe Immune Thrombocytopenia
A Phase 3 study testing rhTPO and Herombopag in people with Immune Thrombocytopenia, run by Yin Jie at 1 site in China.
Trial summary
Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- rhTPO and Herombopag
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female,70 ≥age≥18；
- Diagnosed as primary immune thrombocytopenia；
- Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
- No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
- Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
- There was no history of platelet transfusion one week before treatment.
Who cannot join
- Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
- Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
- Patients deemed unsuitable for enrollment by the investigator；
- Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
- Patients reject to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jie Yin
Suzhou, Jiangsu
Jie Yin, MD.，PhD, +86-512-67781521, yinjie@suda.edu.cn
About this study
Official title: Evaluating the Efficacy and Safety of the Combination of Herombopag and Human Thrombopoietin (rhTPO) in the Treatment of Patients With Severe Immune Thrombocytopenia (ITP)
Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.
Read the detailed description
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.
- Conditions
- Immune Thrombocytopenia
- Being tested
- rhTPO, Herombopag
- Keywords
- immune thrombocytopenia, severe, Herombopag, recombinant human thrombopoietin
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
subcutaneous injection
HerombopagDrug
Orally by mouth
| Study group | Role | What they receive |
|---|---|---|
| rhTPO | Experimental | rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days. Receives: Drug: rhTPO |
| Herombopag | Experimental | Herombopag will be taken orally at 5 mg daily for 28 days. Receives: Drug: Herombopag |
| Herombopag in combination of rhTPO | Experimental | Herombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days Receives: Drug: rhTPO; Drug: Herombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
platelets ≥30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations
Measured: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
The rate and magnitude of the increase in platelet count
The rate and magnitude of the increase in platelet count after treatment
Measured: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Platelet maintenance response time
Platelets stay above 30*10E9/L
Measured: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Secondary outcomes (3)
Platelet fuction
Platelet aggregation function assay and the expression of P selectin on platelet surface
Measured: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
the markers of thrombosis and fibrinolysis
platelet-derived microparticals in plasma, concentration of Plasminogen Activator Inhibitor-1 （PAI-1）, D-D dimer, tissue plasminogen activator （tPA），urokinase-type plasminogen activator （uPA） and Thrombin activatable fibrinolysis inhibitor （TAFI）
Measured: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Thrombotic events
the number/time/site of thrombotic events （lower extremity deep vein thrombosis, pulmonary embolism, intracranial thrombosis, .etc）in participants
Measured: From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Jan 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yin Jie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yin Jie, The First Affiliated Hospital of Soochow University
- Investigators
- Jie Yin, Principal investigator, First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328804
- Sponsor's protocol ID
- SZ-ITP01
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of the Combination of Herombopag and Human Thrombopoietin (rhTPO) in the Treatment of Patients With Severe Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT05328804
- Acronym / sponsor ID
- SZ-ITP01
- Conditions
- Immune Thrombocytopenia
- Keywords
- immune thrombocytopenia, severe, Herombopag, recombinant human thrombopoietin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Yin JieUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Apr 2022 (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.
Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.
Detailed description
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.
| Arm | Type | Receives |
|---|---|---|
| rhTPO | Experimental | Drug: rhTPOrhTPO will be injected subcutaneously at 300 u/kg daily for 14 days. |
| Herombopag | Experimental | Drug: HerombopagHerombopag will be taken orally at 5 mg daily for 28 days. |
| Herombopag in combination of rhTPO | Experimental | Drug: rhTPO, Drug: HerombopagHerombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female,70 ≥age≥18；
- Diagnosed as primary immune thrombocytopenia；
- Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
- No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
- Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
Key exclusion criteria (5 listed)
- Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
- Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
- Patients deemed unsuitable for enrollment by the investigator；
- Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
- Patients reject to participate in the study.
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 |
|---|---|---|
| rhTPOsubcutaneous injection | Drug | Herombopag in combination of rhTPO, rhTPO |
| HerombopagOrally by mouth | Drug | Herombopag, Herombopag in combination of rhTPO |
Primary outcome
Response Rate
Time frame: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
platelets ≥30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations
The rate and magnitude of the increase in platelet count
Time frame: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
The rate and magnitude of the increase in platelet count after treatment
Platelet maintenance response time
Time frame: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Platelets stay above 30*10E9/L
3 secondary outcomes
Platelet fuction
Time frame: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
the markers of thrombosis and fibrinolysis
Time frame: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Thrombotic events
Time frame: From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- 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. This study is not recruiting at the moment.
Jie Yin principal investigator
First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhTPO and Herombopag in people with Immune Thrombocytopenia, run by Yin Jie 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Tian (15850150032, tianhong0718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment). The study lists 3 primary outcomes in all. 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 26 Apr 2022.