Immune ThrombocytopeniaPhase 3NCT02270801
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy
A Phase 3 study testing rhTPO in people with Immune Thrombocytopenia and Pregnancy, run by Shandong University at 1 site in China.
Trial summary
This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Immune Thrombocytopenia, Pregnancy
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Apr 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Subject is between 18-50 years old.
- After 12 weeks gestation.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid or IVIG.
- Patients developed refractoriness to platelet transfusion.
- To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- Willing and able to sign written informed consent.
Who cannot join
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Patients who are deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong University Qilu hospital
Jinan, Shandong, 250012
Ming Hou, MD PhD, +86-531-82169114 ext. 9879, houming@medmail.com.cn
Ming Hou
About this study
Official title: Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP)in Pregnancy: a Single-center Clinical Trial
This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.
Read the detailed description
The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
- Conditions
- Immune Thrombocytopenia, Pregnancy
- Being tested
- rhTPO
- Keywords
- recombinant human thrombopoietin, immune thrombocytopenia, pregnancy
- 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.
rhTPODrug
Also called TPIAO, S20050048/49 (SFDA, China)
rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.
| Study group | Role | What they receive |
|---|---|---|
| rhTPO | Experimental | rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Receives: Drug: rhTPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Response
Response rate (CR+R) at the 14th day, the 10th week from the initial injection of rhTPO, ante partum and one month after delivery. CR is defined as platelet count ≥ 100×109/L, and R is defined as platelet count of >30×109/L with at least a doubling of the baseline value.
Measured: one month after delivery
Secondary outcomes (1)
Safety
Adverse events in patients and infants.
Measured: six months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, MD PhD, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270801
- Sponsor's protocol ID
- rhTPO-ITP-Pregnancy
- Status last verified
- Mar 2016
- First submitted
- 17 Oct 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP)in Pregnancy: a Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT02270801
- Acronym / sponsor ID
- rhTPO-ITP-Pregnancy
- Conditions
- Immune Thrombocytopenia, Pregnancy
- Keywords
- recombinant human thrombopoietin, immune thrombocytopenia, pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 21 Oct 2014 (estimated)
- 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 clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.
Detailed description
The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhTPO | Experimental | Drug: rhTPOrhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is between 18-50 years old.
- After 12 weeks gestation.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid or IVIG.
- Patients developed refractoriness to platelet transfusion.
Key exclusion criteria (6 listed)
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
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: TPIAO, S20050048/49 (SFDA, China)rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. | Drug | rhTPO |
Primary outcome
Early Response
Time frame: one month after delivery
Response rate (CR+R) at the 14th day, the 10th week from the initial injection of rhTPO, ante partum and one month after delivery. CR is defined as platelet count ≥ 100×109/L, and R is defined as platelet count of >30×109/L with at least a doubling of the baseline value.
1 secondary outcome
Safety
Time frame: six months after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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, MD PhD 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 rhTPO in people with Immune Thrombocytopenia and Pregnancy, 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 7 inclusion and 6 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 20 Apr 2016. 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, MD PhD (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?
Early Response (time frame: one month after delivery). 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 20 Apr 2016.