| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chemotherapy-Induced Thrombocytopenia | Drug: Hetrombopag Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Multicentre Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy. |
| Estimated Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | August 30, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hetrombopag treatment
Study is 2:1 randomization ratio (hetrombopag to placebo).
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Drug: Hetrombopag
Hetrombopag oral tablet 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.
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Placebo Comparator: Placebo treatment
Study is 2:1 randomization ratio (hetrombopag to placebo).
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Drug: Placebo
Placebo oral tablet (vehicle) 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Ling Li, MD | 86-400-828-3900 | liling@hrglobe.cn |
| China, Jiangsu | |
| Najing Bayi Hospital | Recruiting |
| Nanjing, Jiangsu, China, 210002 | |
| Contact: Shukui Qin, MD 86-025-80864362 qinsk@csco.org.cn | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 3, 2019 | ||||
| First Posted Date ICMJE | June 6, 2019 | ||||
| Last Update Posted Date | June 6, 2019 | ||||
| Estimated Study Start Date ICMJE | June 1, 2019 | ||||
| Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The proportion of responders. [ Time Frame: Up to the end of Cycle 2 (each cycle is 21 or 28 days) ] Responder is defined as proportion of subjects who do not require platelet transfusion or platelet boosting therapy (rhTPO or rhIL11) in Cycle 1, dose reduction in chemotherapy by >20%, or chemotherapy delay by >4 days in Cycle 2.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy. | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled Multicentre Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy. | ||||
| Brief Summary | Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors and lymphomas. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Chemotherapy-Induced Thrombocytopenia | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
201 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
| Estimated Primary Completion Date | August 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03976882 | ||||
| Other Study ID Numbers ICMJE | HR-TPO-CIT-Ⅲ | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||||
| Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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