ITPPhase 4NCT04089267
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
A Phase 4 study testing TPO in people with ITP, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 21 sites in China.
Trial summary
This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ITP
- What is being tested?
- TPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 21 sitesChina
- Study dates
- Dec 2016to Aug 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, male or female
- For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
- Recurrence after previous treatment with glucocorticoids is ineffective or effective
- No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
- Platelet count before enrollment ≤ 30 × 109 / L, or > 30 × 109 / L but with active bleeding
- Volunteer to participate in the study and sign the informed consent form
Who cannot join
- pregnant or lactating
- Those with a history of thrombosis
- severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
- Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
- In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
- Severe or uncontrollable infections
- have a history of mental illness
- The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Guangdong Second People's Hospital
Guangzhou, Guangdong, 510317
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 511400
Harbin Institute of Hematology and Oncology
Haerbin, Heilongjiang, 150010
Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Lishui City Center Hospital
Lishui, Zhejiang, 323000
Loudi Central Hospital
Loudi, Hunan, 417118
Henan University of Science and Technology First Affiliated Hospital
Luoyang, Henan, 471003
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
First Affiliated Hospital Heilongjiang University of Chinese Medicine
Shenyang, Liaoning, 150040
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Chinese Academy of Medical Sciences Blood Disease Hospital
Tianjin, Tianjin Municipality, 300020
Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,
Ürümqi, Xinjiang
renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, 430060
Xi An Central Hospital
Xi’an, Shanxi, 710499
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang
Xinxiang Central Hospital,
Xinxiang, 453699
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Zhengzhou Central Hospital
Zhengzhou, Henan, 450007
About this study
Official title: Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
Read the detailed description
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study
- Conditions
- ITP
- Being tested
- TPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPODrug
| Study group | Role | What they receive |
|---|---|---|
| experimental group 1 | Experimental | rhTPO injection7500 U ;one time a day; 14 times of administration Receives: Drug: TPO |
| experimental group 2 | Experimental | rhTPO injection15000 U;one time a day;14 times of administration Receives: Drug: TPO |
| experimental group 3 | Experimental | rhTPO injection15000 U;1 time every other day, 7 times; Receives: Drug: TPO |
| experimental group 4 | Experimental | rhTPO injection30000 U；1 time every other day, 7 times; Receives: Drug: TPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Platelet count from baseline on day 14 after the first dose
Measured: for day 14
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
Measured: for day 14
Secondary outcomes (6)
The change in Platelet count from baseline on day 7 and day28 after the first dose
Measured: for day7and day28
the total effective rate of treatment in ITP patients on day 7 and day 28
Measured: for day7and day28
AE
Measured: up to 28days
Incidence of anti-rhTPO antibodies
Measured: up to 28days
Cav
average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state
Measured: up to 28days
AUCss
Measured: up to 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startDec 2016
- Primary completionDec 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ITPStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089267
- Sponsor's protocol ID
- 3sbio-TPO-403
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT04089267
- Acronym / sponsor ID
- 3sbio-TPO-403
- Conditions
- ITP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 13 Sep 2019 (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 is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
Detailed description
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| experimental group 1 | Experimental | Drug: TPOrhTPO injection7500 U ;one time a day; 14 times of administration |
| experimental group 2 | Experimental | Drug: TPOrhTPO injection15000 U;one time a day;14 times of administration |
| experimental group 3 | Experimental | Drug: TPOrhTPO injection15000 U;1 time every other day, 7 times; |
| experimental group 4 | Experimental | Drug: TPOrhTPO injection30000 U；1 time every other day, 7 times; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old, male or female
- For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
- Recurrence after previous treatment with glucocorticoids is ineffective or effective
- No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
- Platelet count before enrollment ≤ 30 × 109 / L, or > 30 × 109 / L but with active bleeding
Key exclusion criteria (8 listed)
- pregnant or lactating
- Those with a history of thrombosis
- severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
- Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
- In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
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 | Drug | experimental group 1, experimental group 2, experimental group 3, experimental group 4 |
Primary outcome
The change in Platelet count from baseline on day 14 after the first dose
Time frame: for day 14
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
Time frame: for day 14
6 secondary outcomes
The change in Platelet count from baseline on day 7 and day28 after the first dose
Time frame: for day7and day28
the total effective rate of treatment in ITP patients on day 7 and day 28
Time frame: for day7and day28
AE
Time frame: up to 28days
Incidence of anti-rhTPO antibodies
Time frame: up to 28days
Cav
Time frame: up to 28days
AUCss
Time frame: up to 28days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TPO in people with ITP, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 21 sites 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 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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Platelet count from baseline on day 14 after the first dose (time frame: for day 14). The study lists 2 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 13 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.