ThrombocytopeniaPhase 4HUrhTPOCITPNCT03633019
High-dose Use of rhTPO in CIT Patients
A Phase 4 study testing rhTPO in people with Thrombocytopenia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- rhTPO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2018to 31 Dec 2020
- 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
- patients with malignant solid tumor
- moderate or severe chemotherapy-induced thrombocytopenia, platelet counts less than 50×109/L
- plan to use rhTPO
- be willing to adopt appropriate methods of contraception during the study period and 8 weeks after the end of the study; women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days before entering the study and the result must be negative
- volunteer to participate in the study, sign the informed consent, and cooperate with good compliance
Who cannot join
- having other diseases that can lead to thrombocytopenia, such as aplastic anemia, myelodysplastic syndrome, leukemia, lymphoproliferative disease, immune thrombocytopenic purpura, thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, thyroid disease, liver cirrhosis, hypersplenism, etc.
- using other non-chemotherapeutic drugs that can cause thrombocytopenia, such as sulfonamides, etc
- with long-term wound or great worry of gastrointestinal bleeding
- with venous thrombosis that need thrombolytic or anticoagulant therapy or high risk of venous thromboembolism
- with infection requiring antibiotic treatment
- History of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders
Show all 15Show fewer
- patients with Hepatitis B(except inactive carrier) or Hepatitis C
- with serious heart disease or cerebrovascular disease
- with heart failure or heart failure history
- with severe anemia that requires long-term use of recombinant human erythropoietin
- congenital thrombocytopenia
- has been used medication for thrombocytopenia
- pregnancy or lactation
- participate in other clinical researchers at the same time
- not suitable to participate in the study in researchers'opinion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Lingxiao Zhang, doctor, +8618066910386, 514324869@qq.com
About this study
Official title: High-dose Use of Recombinant Human Thrombopoietin in Patients With Moderate or Severe Thrombocytopenia Induced by Chemotherapy
The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days). Finally, the clinical data will be collected and analyzed to validate the efficacy and safety of high-dose rhTPO therapy.
Read the detailed description
Chemotherapy-induced thrombocytopenia is a common toxic reaction of chemotherapeutic drugs, which may lead to dose reduction, delay or even termination of chemotherapy. Severe thrombocytopenia may cause bleeding and threaten patient's life. rhIL-11 and rhTPO are the only two drugs approved by China Food and Drug Administration for the treatment of chemotherapy-induced thrombocytopenia. The recommended dosage of rhTPO is 300U/kg. Clinical practice in the real world is full of changes and restraints. In the treatment of thrombocytopenia induced by chemotherapy, the actual dose of rhTPO is often below 300U/kg, due to factors such as Specs, economy and convenience. If the dose of rhTPO is insufficient, it can not give full play to the effect and thus can not achieve the purpose of rapid recovery of platelets. Previous clinical studies observed that the effect of rhTPO depends on the given dose. Dosage in the range of 75U-600U/kg of rhTPO were safe in human. While the 75U/kg dose group had no significant effect on the platelet count elevation, the platelet count in other three dose groups of 150U/kg, 300U/kg and 600U/kg increased by 24%, 32%, and 52% (P < 0.01). This research is a real-world study designed to verify the safety and efficacy of high-dose rhTPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days) and the clinical data will be collected and analyzed. It is based on the patient's actual condition and the treatment measure is more consistent with the clinical practice. The results of this study are expected to provide new options and references for clinical treatment of thrombocytopenia induced by chemotherapy.
- Conditions
- Thrombocytopenia
- Being tested
- rhTPO
- Keywords
- thrombocytopenia, rhTPO, real-world study, safety, efficacy
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
Also called Recombinant Human Thrombopoietin Injection
high dose rhTPO ih
| Study group | Role | What they receive |
|---|---|---|
| high-dose rhTPO | Experimental | rhTPO (300-600U/kg/day), ih, until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L Receives: Drug: rhTPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of grade 3 and 4 thrombocytopenia
Period of time when the platelet counts is lower 75×109/L, days
Measured: From time of randomization to the time of platelet counts recover to 75×109/L and above, assessed up to 20days
Secondary outcomes (3)
Adverse event
Any related adverse event during the study according to NCI-CTCAE 4.03, count
Measured: From randomization until 2 days after treatment completion or withdrawal of patient, whichever comes first, assessed up to 22days
Platelets transfusion
Platelets transfusion during the study, number of times
Measured: From randomization to the time of platelets transfusion, assessed up to 20days
platelet count nadir
the lowest platelet count
Measured: From randomization to the time of the lowest value of platelets, assessed up to 20days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start28 Sep 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenyang Pharmaceutical University
- Responsible party
- Sponsor
- Investigators
- Lingxiao Zhang, doctor, Principal investigator, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633019
- Sponsor's protocol ID
- XJTU1AF2018LSK-056
- Acronym
- HUrhTPOCITP
- Status last verified
- Jun 2018
- First submitted
- 2 Aug 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Use of Recombinant Human Thrombopoietin in Patients With Moderate or Severe Thrombocytopenia Induced by Chemotherapy
- ClinicalTrials.gov ID
- NCT03633019
- Acronym / sponsor ID
- HUrhTPOCITP / XJTU1AF2018LSK-056
- Conditions
- Thrombocytopenia
- Keywords
- thrombocytopenia, rhTPO, real-world study, safety, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Shenyang Pharmaceutical University
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Aug 2018 (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.
The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days). Finally, the clinical data will be collected and analyzed to validate the efficacy and safety of high-dose rhTPO therapy.
Detailed description
Chemotherapy-induced thrombocytopenia is a common toxic reaction of chemotherapeutic drugs, which may lead to dose reduction, delay or even termination of chemotherapy. Severe thrombocytopenia may cause bleeding and threaten patient's life. rhIL-11 and rhTPO are the only two drugs approved by China Food and Drug Administration for the treatment of chemotherapy-induced thrombocytopenia. The recommended dosage of rhTPO is 300U/kg. Clinical practice in the real world is full of changes and restraints. In the treatment of thrombocytopenia induced by chemotherapy, the actual dose of rhTPO is often below 300U/kg, due to factors such as Specs, economy and convenience. If the dose of rhTPO is insufficient, it can not give full play to the effect and thus can not achieve the purpose of rapid recovery of platelets. Previous clinical studies observed that the effect of rhTPO depends on the given dose. Dosage in the range of 75U-600U/kg of rhTPO were safe in human. While the 75U/kg dose group had no significant effect on the platelet count elevation, the platelet count in other three dose groups of 150U/kg, 300U/kg and 600U/kg increased by 24%, 32%, and 52% (P < 0.01). This research is a real-world study designed to verify the safety and efficacy of high-dose rhTPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days) and the clinical data will be collected and analyzed. It is based on the patient's actual condition and the treatment measure is more consistent with the clinical practice. The results of this study are expected to provide new options and references for clinical treatment of thrombocytopenia induced by chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-dose rhTPO | Experimental | Drug: rhTPOrhTPO (300-600U/kg/day), ih, until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with malignant solid tumor
- moderate or severe chemotherapy-induced thrombocytopenia, platelet counts less than 50×109/L
- plan to use rhTPO
- be willing to adopt appropriate methods of contraception during the study period and 8 weeks after the end of the study; women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days before entering the study and the result must be negative
- volunteer to participate in the study, sign the informed consent, and cooperate with good compliance
Key exclusion criteria (15 listed)
- having other diseases that can lead to thrombocytopenia, such as aplastic anemia, myelodysplastic syndrome, leukemia, lymphoproliferative disease, immune thrombocytopenic purpura, thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, thyroid disease, liver cirrhosis, hypersplenism, etc.
- using other non-chemotherapeutic drugs that can cause thrombocytopenia, such as sulfonamides, etc
- with long-term wound or great worry of gastrointestinal bleeding
- with venous thrombosis that need thrombolytic or anticoagulant therapy or high risk of venous thromboembolism
- with infection requiring antibiotic treatment
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 |
|---|---|---|
| rhTPOAlso: Recombinant Human Thrombopoietin Injectionhigh dose rhTPO ih | Drug | high-dose rhTPO |
Primary outcome
Duration of grade 3 and 4 thrombocytopenia
Time frame: From time of randomization to the time of platelet counts recover to 75×109/L and above, assessed up to 20days
Period of time when the platelet counts is lower 75×109/L, days
3 secondary outcomes
Adverse event
Time frame: From randomization until 2 days after treatment completion or withdrawal of patient, whichever comes first, assessed up to 22days
Platelets transfusion
Time frame: From randomization to the time of platelets transfusion, assessed up to 20days
platelet count nadir
Time frame: From randomization to the time of the lowest value of platelets, assessed up to 20days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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.
Lingxiao Zhang, doctor principal investigator
First Affiliated Hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhTPO in people with Thrombocytopenia, run by First Affiliated Hospital Xi'an Jiaotong University 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 5 inclusion and 15 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 30 Oct 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingxiao Zhang, doctor (+8618066910386, 514324869@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of grade 3 and 4 thrombocytopenia (time frame: From time of randomization to the time of platelet counts recover to 75×109/L and above, assessed up to 20days). 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 30 Oct 2018.