ThrombocytopeniaPhase 3NCT01805648
Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP
A Phase 3 study testing rhTPO in people with Thrombocytopenia and Immune Thrombocytopenia, run by Peking Union Medical College at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO . Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Thrombocytopenia, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
- 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2013
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura).
- Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy.
- Two consecutive platelet counts (not in the same day) < 30×10^9/L.
- Subject is willing and able to provide written informed consent.
Who cannot join
- Pregnancy or breast feeding.
- Having a medical history of thrombosis.
- Significant abnormal cardio-pulmonary function.
- Abnormal liver and kidney function:
- a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl);
- a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range.
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- a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range.
- Synchronous tumor.
- Cannot adopt adequate contraceptive precautions during the course of the study.
- Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ).
- Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
Trial locations and contacts
1 site in 1 country.
Yongqiang Zhao, Dr. contact
Shujie Wang contact
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Shujie Wang, Dr., yangwl2007@yahoo.cn
Yongqiang Zhao, Dr.
About this study
Official title: A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia
The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .
Read the detailed description
The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment.
Platelet count, bleeding and other symptoms will be evaluated before and after treatment.
Platelet transfusion will be administered to subjects with active bleeding symptoms.
Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.
- Being tested
- rhTPO
- Keywords
- ITP, rhTPO
- Medical subject headings
- Thrombocytopenia, 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 Recombinant Human Thrombopoietin, Recombinant Human TPO
Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10^9/L～100×10^9/L.
| Study group | Role | What they receive |
|---|---|---|
| rhTPO | Experimental | Active investigational product Receives: Drug: rhTPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)
Measured: up to 16 weeks per subject
Secondary outcomes (2)
The effective rate of maintenance treatments adopting different frequency of administration
Measured: up to 16 weeks per subject
Number of subjects with Adverse Events as a Measure of Safety
Measured: up to 18 weeks per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Responsible party
- Principal investigator, Yongqiang Zhao, Peking Union Medical College
- Investigators
- Yongqiang Zhao, Dr., Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805648
- Sponsor's protocol ID
- TPOzyq120725
- Status last verified
- Mar 2013
- First submitted
- 22 Feb 2013
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01805648
- Acronym / sponsor ID
- TPOzyq120725
- Keywords
- ITP, rhTPO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Collaborators
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Study start
- Feb 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 6 Mar 2013 (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 purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .
Detailed description
The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment.
Platelet count, bleeding and other symptoms will be evaluated before and after treatment.
Platelet transfusion will be administered to subjects with active bleeding symptoms.
Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.
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: rhTPOActive investigational product |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura).
- Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy.
- Two consecutive platelet counts (not in the same day) < 30×10^9/L.
- Subject is willing and able to provide written informed consent.
Key exclusion criteria (11 listed)
- Pregnancy or breast feeding.
- Having a medical history of thrombosis.
- Significant abnormal cardio-pulmonary function.
- Abnormal liver and kidney function:
- Synchronous tumor.
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, Recombinant Human TPOSubcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10^9/L～100×10^9/L. | Drug | rhTPO |
Primary outcome
The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)
Time frame: up to 16 weeks per subject
2 secondary outcomes
The effective rate of maintenance treatments adopting different frequency of administration
Time frame: up to 16 weeks per subject
Number of subjects with Adverse Events as a Measure of Safety
Time frame: up to 18 weeks per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
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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.
Yongqiang Zhao, Dr. contact
Shujie Wang contact
Yongqiang Zhao, Dr. principal investigator
Peking Union Medical College
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 Thrombocytopenia and Immune Thrombocytopenia, run by Peking Union Medical College 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 4 inclusion and 11 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 6 Mar 2013. 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 Yongqiang Zhao, Dr. (535114726@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L) (time frame: up to 16 weeks 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 6 Mar 2013.