Immune ThrombocytopeniaPhase 3NCT03492515
Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia
A Phase 3 study testing recombinant human thrombopoietin and Platelet Concentrate in people with Immune Thrombocytopenia, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- recombinant human thrombopoietin and Platelet Concentrate
- Type of treatment
- 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 May 2018to 1 May 2022
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet the diagnostic criteria for immune thrombocytopenia.
- 18-50 years of age; gestational age over 32 weeks;
- No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted);
- Platelet transfusion was not effective.
- Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding.
- No obvious abnormalities in liver and kidney function had (1.5 times higher than normal limit of the serum urea nitrogen, creatinine, serum transaminase and bilirubin );
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- No severe cardiac and pulmonary dysfunction;
- No history of mental illness;
- Voluntarily signed written informed consent.
Who cannot join
- A history of serious allergies to biologics;
- The history of thrombosis;
- Thromboembolic or hemorrhagic disease;
- Patients who are deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Clinical Study of Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia
The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.
Read the detailed description
The project is undertaken by Qilu Hospital of Shandong University and other 6 well-known hospitals in China. The investigators anticipate to undertaking a concurrent control, multicentre trial including 60 pregnancy associated ITP adult patients which are ineffective for first-line treatment or platelets infusion and 30 healthy pregnancy control. 30 of the ITP patients are selected to receive rhTPO(given different dose according to the platelet count, the risk of bleeding and delivery), the other ITP patients are selected not to receive rhTPO. Platelet count, bleeding and other symptoms of ITP patients and their newborns are evaluated after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the rhTPO for the treatment of pregnancy with ITP.
- Conditions
- Immune Thrombocytopenia
- Being tested
- recombinant human thrombopoietin, Platelet Concentrate
- Keywords
- immune thrombocytopenia
- 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.
recombinant human thrombopoietinDrug
Also called rhTPO
If platelet count <30×10^9/L and with haemorrhage or risk of bleeding,the patients began to receive subcutaneous injection of TPO with the dose of 300 Unit/kg qd,duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qod;If platlet count ≥100×109/L, stop this treatment;After delivery, if platelet count <30×10^9/L and with haemorrhage or risk of bleeding,subcutaneous injection of TPO with the dose of 300 Unit/kg qd or qod will be given at a duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qw;If platlet count ≥100×109/L, stop the treatment.
Platelet ConcentrateDrug
according to the their conditions, use if necessary
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Accepting the treatment of rhTPO according platelet and bleeding condition Receives: Drug: recombinant human thrombopoietin |
| non-administered group | Active comparator | No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions. Receives: Drug: Platelet Concentrate |
| healthy control group | No intervention | Healthy pregnant women and no use of any medicine。 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count during delivery
Platelet count during delivery will be assessed
Measured: up to 2 years per subject
Secondary outcomes (3)
Adverse events in neonates
The number and frequency of therapy associated adverse events in neonates
Measured: up to 2 years per subject
platlet count of newborns
Platelet counts of D1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs.
Measured: up to 42 days per newborn
Adverse events in parturients
The number and frequency of therapy associated adverse events in parturients
Measured: up to 2 years per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2022 (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
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, First Affiliated Hospital of Chongqing Medical University, Linyi People's Hospital, The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital, Zhongshan Bo Ai Hospital
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou,, Dr, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492515
- Sponsor's protocol ID
- rhTPO in pregnancy of ITP
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT03492515
- Acronym / sponsor ID
- rhTPO in pregnancy of ITP
- Conditions
- Immune Thrombocytopenia
- Keywords
- immune thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, First Affiliated Hospital of Chongqing Medical University, Linyi People's Hospital, The Affiliated Hospital of Qingdao University, Shandong Provincial Hospital, Zhongshan Bo Ai Hospital
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 10 Apr 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 purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.
Detailed description
The project is undertaken by Qilu Hospital of Shandong University and other 6 well-known hospitals in China. The investigators anticipate to undertaking a concurrent control, multicentre trial including 60 pregnancy associated ITP adult patients which are ineffective for first-line treatment or platelets infusion and 30 healthy pregnancy control. 30 of the ITP patients are selected to receive rhTPO(given different dose according to the platelet count, the risk of bleeding and delivery), the other ITP patients are selected not to receive rhTPO. Platelet count, bleeding and other symptoms of ITP patients and their newborns are evaluated after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the rhTPO for the treatment of pregnancy with ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: recombinant human thrombopoietinAccepting the treatment of rhTPO according platelet and bleeding condition |
| non-administered group | Active comparator | Drug: Platelet ConcentrateNo rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions. |
| healthy control group | No intervention | –Healthy pregnant women and no use of any medicine。 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Meet the diagnostic criteria for immune thrombocytopenia.
- 18-50 years of age; gestational age over 32 weeks;
- No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted);
- Platelet transfusion was not effective.
- Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding.
Key exclusion criteria (4 listed)
- A history of serious allergies to biologics;
- The history of thrombosis;
- Thromboembolic or hemorrhagic disease;
- Patients who are deemed unsuitable for the study by the investigator.
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 |
|---|---|---|
| recombinant human thrombopoietinAlso: rhTPOIf platelet count <30×10^9/L and with haemorrhage or risk of bleeding,the patients began to receive subcutaneous injection of TPO with the dose of 300 Unit/kg qd,duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qod;If platlet count ≥100×109/L, stop this treatment;After delivery, if platelet count <30×10^9/L and with haemorrhage or risk of bleeding,subcutaneous injection of TPO with the dose of 300 Unit/kg qd or qod will be given at a duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qw;If platlet count ≥100×109/L, stop the treatment. | Drug | experimental group |
| Platelet Concentrateaccording to the their conditions, use if necessary | Drug | non-administered group |
Primary outcome
Platelet count during delivery
Time frame: up to 2 years per subject
Platelet count during delivery will be assessed
3 secondary outcomes
Adverse events in neonates
Time frame: up to 2 years per subject
platlet count of newborns
Time frame: up to 42 days per newborn
Adverse events in parturients
Time frame: up to 2 years per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- 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.
Ming Hou,, Dr principal investigator
Shandong 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 recombinant human thrombopoietin and Platelet Concentrate in people with Immune Thrombocytopenia, run by Shandong 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 9 inclusion and 4 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 10 Apr 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 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 Ming Hou, Dr (+86-531-82169114 ext. 9879, houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet count during delivery (time frame: up to 2 years per subject). 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 10 Apr 2018.