Immune ThrombocytopeniaPhase 3NCT02139501
An Investigation of rhTPO With Different Frequencies in the Management of ITP
A Phase 3 study testing Recombinant Human Thrombopoietin (rhTPO) in people with Immune Thrombocytopenia, run by Shandong University at 1 site in China.
Trial summary
The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Recombinant Human Thrombopoietin (rhTPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Jan 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject is ≥18 years old, may be male or female.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid.
- 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.
- Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- 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)
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- 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.
About this study
Official title: A Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP)
The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
Read the detailed description
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 30 primary ITP adult patients from 3 medical centers in China. They will be randomly assigned in a 1:1:1 ratio into three groups .The patients in group A (total 10 patients) will receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days;The patients in group B will receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.The patients in group C will receive rhTPO at a dose of 300Units/kg ,daily for 7 consecutive days .All the patients will follow with a flexible dosage depending on platelet count during the following 12 weeks.
Platelet counts, bleeding and other symptoms were evaluated before and after treatment, in order to evaluate the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
- Conditions
- Immune Thrombocytopenia
- Being tested
- Recombinant Human Thrombopoietin (rhTPO)
- Keywords
- Recombinant Human Thrombopoietin, Dose and frequency, 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 Thrombopoietin (rhTPO)Drug
Also called tpiao, Recombinant Human Thrombopoietin, Recombinant Human TPO
rhTPO was given intravenously at a dose of300Units/kg ,daily for 14 consecutive days;at a dose of 300Units/kg ,one times every other day for 7 times; or at a dose of 300Units/kg ,daily for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| rhTPO, 300Units/kg ,daily for 14 consecutive days | Experimental | 10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days Receives: Drug: Recombinant Human Thrombopoietin (rhTPO) |
| rhTPO, 300Units/kg ,one times every other day for 7 times | Experimental | 10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times. Receives: Drug: Recombinant Human Thrombopoietin (rhTPO) |
| rhTPO, 300Units/kg ,daily for 7 consecutive days | Experimental | 10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days. Receives: Drug: Recombinant Human Thrombopoietin (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 and the 14th week from the initial injection of rhTPO. CR is defined as platelet count ≥ 100×10^9/L, and R is defined as platelet count of >30 × 10^9/L with a least a doubling of the baseline value.
Measured: 14 days
Secondary outcomes (1)
Safety
The type and frequency of therapy associated adverse events
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, Dr, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139501
- Sponsor's protocol ID
- ITP-Thrombopoietin
- Status last verified
- Nov 2014
- First submitted
- 13 May 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
- A Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT02139501
- Acronym / sponsor ID
- ITP-Thrombopoietin
- Conditions
- Immune Thrombocytopenia
- Keywords
- Recombinant Human Thrombopoietin, Dose and frequency, Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 May 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.
The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
Detailed description
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 30 primary ITP adult patients from 3 medical centers in China. They will be randomly assigned in a 1:1:1 ratio into three groups .The patients in group A (total 10 patients) will receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days;The patients in group B will receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.The patients in group C will receive rhTPO at a dose of 300Units/kg ,daily for 7 consecutive days .All the patients will follow with a flexible dosage depending on platelet count during the following 12 weeks.
Platelet counts, bleeding and other symptoms were evaluated before and after treatment, in order to evaluate the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rhTPO, 300Units/kg ,daily for 14 consecutive days | Experimental | Drug: Recombinant Human Thrombopoietin (rhTPO)10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days |
| rhTPO, 300Units/kg ,one times every other day for 7 times | Experimental | Drug: Recombinant Human Thrombopoietin (rhTPO)10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times. |
| rhTPO, 300Units/kg ,daily for 7 consecutive days | Experimental | Drug: Recombinant Human Thrombopoietin (rhTPO)10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is ≥18 years old, may be male or female.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid.
- To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- Willing and able to sign written informed consent.
Key exclusion criteria (8 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.
- Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- 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)
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 Thrombopoietin (rhTPO)Also: tpiao, Recombinant Human Thrombopoietin, Recombinant Human TPOrhTPO was given intravenously at a dose of300Units/kg ,daily for 14 consecutive days;at a dose of 300Units/kg ,one times every other day for 7 times; or at a dose of 300Units/kg ,daily for 7 consecutive days | Drug | rhTPO, 300Units/kg ,daily for 14 consecutive days, rhTPO, 300Units/kg ,daily for 7 consecutive days, rhTPO, 300Units/kg ,one times every other day for 7 times |
Primary outcome
Early Response
Time frame: 14 days
response rate (CR+R) at the 14th day and the 14th week from the initial injection of rhTPO. CR is defined as platelet count ≥ 100×10^9/L, and R is defined as platelet count of >30 × 10^9/L with a least a doubling of the baseline value.
1 secondary outcome
Safety
Time frame: 1 years
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 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, 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 (rhTPO) 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 5 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 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?
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?
Early Response (time frame: 14 days). 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.