4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Study Description
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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Thrombocytopenia Drug: Hetrombopag Drug: Placebo Phase 3

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: Hetrombopag treatment
Study is 2:1 randomization ratio (hetrombopag to placebo).
Drug: Hetrombopag
Hetrombopag oral tablet 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.

Placebo Comparator: Placebo treatment
Study is 2:1 randomization ratio (hetrombopag to placebo).
Drug: Placebo
Placebo oral tablet (vehicle) 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration from initiating chemotherapy to the time presenting the nadir of platelet count [ Time Frame: Up to the end of Cycle 1 (each cycle is 21 or 28 days) ]
  2. Proportion of subjects who do not require platelet transfusion or platelet boosting therapy (rhTPO or rhIL11) [ Time Frame: Up to the end of Cycle 1 (each cycle is 21 or 28 days) ]
  3. Proportion of subjects who do not require dose reduction in chemotherapy by >20% [ Time Frame: Up to the end of Cycle 2 (each cycle is 21 or 28 days) ]
  4. Proportion of subjects who do not require chemotherapy delay by >4 days [ Time Frame: Up to the end of Cycle 2 (each cycle is 21 or 28 days) ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18-75 years of age;
  • Participant with a confirmed diagnosis of solid tumor or lymphoma by histopathological or cytological examination receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents: Antimetabolie Antineoplastic agents including gemcitabine, Antitumor Platinum drugs including Carboplatin or cisplatin, Anthracycline Alkylating agent, Alkylating agent or other chemotherapy which could induce thrombocytopenia;
  • Participant experienced moderate thrombocytopenia, defined as two platelet counts within 30×109-75×109/L measured at least 24 h apart, during the previous chemotherapy cycle;
  • In the previous day before dosing of Hemtrombopag (Day -1), subjects has a platelet count within 100×109-200×109/L, neutrophil count≥1.5×109/L, haemoglobin≥90g/L;
  • Subject has a life expectancy≥12 weeks at screening and is able to receive at least two additional cycles of the current chemotherapy regimen when screening;
  • ECOG performance status 0-1;
  • Subjects of childbearing potential must agree to use a highly effective method of contraception, except subjects with surgically sterile;
  • Subject is willing to participate in the study, and Subject must provide written informed consent.

Exclusion Criteria:

  • Subject has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of Screening;
  • Subject has any history of hematologic diseases other than lymphoma and CIT;
  • Solid tumor with invasion of bone marrow;
  • Subject has received radiotherapy;
  • Subject has a history of arterial or venous thrombosis within 6 months of Screening;
  • Subject has a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade 3/4, arrhythmia known to increase the risk of thromboembolic events (eg, atrial fibrillation), coronary artery stent placement, angioplasty, or coronary artery bypass graft;
  • Subject has previously received a thrombopoietin receptor agonist (eg, eltrombopag), rhTPO or rhIL11 for the treatment of CIT;
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ling Li, MD 86-400-828-3900 liling@hrglobe.cn

Locations
Layout table for location information
China, Jiangsu
Najing Bayi Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Shukui Qin, MD    86-025-80864362    qinsk@csco.org.cn   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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
 (submitted: June 4, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Duration from initiating chemotherapy to the time presenting the nadir of platelet count [ Time Frame: Up to the end of Cycle 1 (each cycle is 21 or 28 days) ]
  • Proportion of subjects who do not require platelet transfusion or platelet boosting therapy (rhTPO or rhIL11) [ Time Frame: Up to the end of Cycle 1 (each cycle is 21 or 28 days) ]
  • Proportion of subjects who do not require dose reduction in chemotherapy by >20% [ Time Frame: Up to the end of Cycle 2 (each cycle is 21 or 28 days) ]
  • Proportion of subjects who do not require chemotherapy delay by >4 days [ Time Frame: Up to the end of Cycle 2 (each cycle is 21 or 28 days) ]
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
Condition  ICMJE Chemotherapy-Induced Thrombocytopenia
Intervention  ICMJE
  • Drug: Hetrombopag
    Hetrombopag oral tablet 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.
  • Drug: Placebo
    Placebo oral tablet (vehicle) 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.
Study Arms  ICMJE
  • Experimental: Hetrombopag treatment
    Study is 2:1 randomization ratio (hetrombopag to placebo).
    Intervention: Drug: Hetrombopag
  • Placebo Comparator: Placebo treatment
    Study is 2:1 randomization ratio (hetrombopag to placebo).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
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:

  • Men and women, 18-75 years of age;
  • Participant with a confirmed diagnosis of solid tumor or lymphoma by histopathological or cytological examination receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents: Antimetabolie Antineoplastic agents including gemcitabine, Antitumor Platinum drugs including Carboplatin or cisplatin, Anthracycline Alkylating agent, Alkylating agent or other chemotherapy which could induce thrombocytopenia;
  • Participant experienced moderate thrombocytopenia, defined as two platelet counts within 30×109-75×109/L measured at least 24 h apart, during the previous chemotherapy cycle;
  • In the previous day before dosing of Hemtrombopag (Day -1), subjects has a platelet count within 100×109-200×109/L, neutrophil count≥1.5×109/L, haemoglobin≥90g/L;
  • Subject has a life expectancy≥12 weeks at screening and is able to receive at least two additional cycles of the current chemotherapy regimen when screening;
  • ECOG performance status 0-1;
  • Subjects of childbearing potential must agree to use a highly effective method of contraception, except subjects with surgically sterile;
  • Subject is willing to participate in the study, and Subject must provide written informed consent.

Exclusion Criteria:

  • Subject has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of Screening;
  • Subject has any history of hematologic diseases other than lymphoma and CIT;
  • Solid tumor with invasion of bone marrow;
  • Subject has received radiotherapy;
  • Subject has a history of arterial or venous thrombosis within 6 months of Screening;
  • Subject has a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade 3/4, arrhythmia known to increase the risk of thromboembolic events (eg, atrial fibrillation), coronary artery stent placement, angioplasty, or coronary artery bypass graft;
  • Subject has previously received a thrombopoietin receptor agonist (eg, eltrombopag), rhTPO or rhIL11 for the treatment of CIT;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP