Chronic Idiopathic Thrombocytopenic PurpuraPhase 1NCT02614846
Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients
A Phase 1 study testing Hetrombopag Olamine in people with Chronic Idiopathic Thrombocytopenic Purpura, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Idiopathic Thrombocytopenic Purpura
- What is being tested?
- Hetrombopag Olamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Mar 2016
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of chronic ITP,a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia.
- Patients had a platelet count of less than 30,000/µL both in the screening period and baseline.
- Subjects who are refractory or have relapsed after at least one prior ITP therapy.
- Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
- Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
- A complete blood count (CBC), within the reference range, with the following exceptions.
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- Platelets <30×109/L is required for inclusion .
- Hemoglobin: females and males 10.0 g/dl are eligible for inclusion.
- Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion.
- 7.PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
- 8.Female subjects have a negative result with HCG testing in the screening period and baseline.
Who cannot join
- Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
- Subjects diagnosed with tumor.
- Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block.
- Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
- Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
- Treatment with Rituximab or Splenectomy within the lat 6 months.
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- Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days or five half-lives (whichever is longer).
- Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study.
- Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
Trial locations and contacts
1 site in 1 country.
Yu Hu, Ph.D contact
Heng Mei, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and technology
Wuhan, Hubei, 430022
Yu Hu, Ph.D, dr_huyu@126.com
Yu Hu, Ph.D
About this study
Official title: A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura
This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag.
- Being tested
- Hetrombopag Olamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag Olamine | Experimental | All the subjects receive 6 weeks Hetrombopag Olamine dosing, 5mg for the first 2 weeks, 2.5mg or 7.5mg for the last 4 weeks according to the PLT counting. Receives: Drug: Hetrombopag Olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with adverse events as a measure of safety and tolerability.
Measured: From Day 1 to Day 70.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614846
- Sponsor's protocol ID
- HR-TPO- Ie-ITP
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT02614846
- Acronym / sponsor ID
- HR-TPO- Ie-ITP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 25 Nov 2015 (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 study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag Olamine | Experimental | Drug: Hetrombopag OlamineAll the subjects receive 6 weeks Hetrombopag Olamine dosing, 5mg for the first 2 weeks, 2.5mg or 7.5mg for the last 4 weeks according to the PLT counting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Platelets <30×109/L is required for inclusion .
- Hemoglobin: females and males 10.0 g/dl are eligible for inclusion.
- Absolute neutrophil count (ANC) ≥1500/µL (1.5×109/L) is required for inclusion.
- 7.PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
- 8.Female subjects have a negative result with HCG testing in the screening period and baseline.
Key exclusion criteria (9 listed)
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 |
|---|---|---|
| Hetrombopag Olamine | Drug | Hetrombopag Olamine |
Primary outcome
The number of subjects with adverse events as a measure of safety and tolerability.
Time frame: From Day 1 to Day 70.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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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.
Yu Hu, Ph.D contact
Heng Mei, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hetrombopag Olamine in people with Chronic Idiopathic Thrombocytopenic Purpura, run by Jiangsu HengRui Medicine Co., Ltd. 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 11 inclusion and 9 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 25 Nov 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yu Hu, Ph.D (dr_huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with adverse events as a measure of safety and tolerability. (time frame: From Day 1 to Day 70.). 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 25 Nov 2015.