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出境医 / 临床实验 / A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)

A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)

Study Description
Brief Summary:
This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.

Condition or disease Intervention/treatment Phase
Acquired Thrombotic Thrombocytopenic Purpura Drug: Anfibatide Drug: Placebos Phase 2

Detailed Description:
The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma（FFP）and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : November 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Anfibatide Drug: Anfibatide
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
Other Name: Anti-platelet thrombolysin for injection
Placebo Comparator: Placebo Drug: Placebos
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
Outcome Measures
Primary Outcome Measures :
  1. Time to response of treatment [ Time Frame: up to 21days ]
    Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l


Secondary Outcome Measures :
  1. Remission rate [ Time Frame: up to 21days ]
    Number of subjects with remission


Other Outcome Measures:
  1. Complete remission rate [ Time Frame: up to 21 days ]
    Number of subjects with complete remission

  2. Number of plasma exchange [ Time Frame: up to 21 days ]
    The number of plasma exchange to achieved remission.

  3. Volume of plasma [ Time Frame: up to 21 days ]
    The volume of plasma to achieved remission.

  4. Time to achieve threshold values of biological markers. [ Time Frame: up to 3 months ]
    The biological markers include platelets，LDH and creatinine.

  5. Total mortality [ Time Frame: up to 21days and the ensuing 30 days ]
    Total mortality within the plasma exchange treatment period and the ensuing 30 days.

  6. Number of exacerbations of TTP and time to first exacerbation of TTP. [ Time Frame: up to 1 month ]
    Exacerbation is defined as recurrent thrombocytopenia following a response and requiring a reinitiation of daily plasma exchange treatment after ≥ 1 day but ≤ 30 days of no plasma exchange treatment.

  7. Number of subjects relapsing of TTP for maximum of 3 months and time to first relapse of TTP. [ Time Frame: up to 3 months ]
    Relapse is defined as novo event of TTP that occurs later than 30 days after the last plasma exchange.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female and male subjects with 18 years of age or older.
  2. Subjects with diagnosis of TTP.
  3. Necessitating plasma exchange.
  4. Obtained, signed and dated informed consent.

Exclusion Criteria:

  1. Platelet count greater or equal to 100*10^9/μL.
  2. Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate <30ml/min.
  3. Uncontrolled severe active infection.
  4. Known congenital TTP.
  5. Subjects with malignant tumors in the past 5 years.
  6. Other diseases that cause microangiopathy hemolytic anemia and thrombocytopenia, such as disseminated intravascular coagulation (DIC), antiphospholipid antibody syndrome, hemolytic uremic syndrome, malignant hypertension, and transplant-related microangiopathy.
  7. Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
  8. Severe active bleeding or progressive aggravation of bleeding symptoms.
  9. Subjects who have received plasmapheresis during the treatment of the onset of the disease.
  10. Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
  11. Subject who have participated in other clinical trials related to Anfibatide.
  12. Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
  13. Life expectation less than 1 week.
  14. Known to be allergic to the drugs or ingredients in the study.
  15. Inability to follow programme requirements and procedures.
  16. Subjects who are not eligible to participate in this clinical study as determined by the investigator.
Contacts and Locations

Contacts
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Contact: Weili Zhao, MD 13512112076 zhaoweili-sih@163.com

Locations
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China, Shanghai
Shanghai Ruijing Hospital
Shanghai, Shanghai, China
Contact: Weili Zhao, MD    13512112076    zhaoweili-sih@163.com   
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
Layout table for investigator information
Study Director: Weili Zhao, MD Shanghai Ruijing Hospital
Tracking Information
First Submitted Date  ICMJE July 15, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 17, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Time to response of treatment [ Time Frame: up to 21days ]
Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019) 		Remission rate [ Time Frame: up to 21days ]
Number of subjects with remission
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 15, 2019)
  • Complete remission rate [ Time Frame: up to 21 days ]
    Number of subjects with complete remission
  • Number of plasma exchange [ Time Frame: up to 21 days ]
    The number of plasma exchange to achieved remission.
  • Volume of plasma [ Time Frame: up to 21 days ]
    The volume of plasma to achieved remission.
  • Time to achieve threshold values of biological markers. [ Time Frame: up to 3 months ]
    The biological markers include platelets，LDH and creatinine.
  • Total mortality [ Time Frame: up to 21days and the ensuing 30 days ]
    Total mortality within the plasma exchange treatment period and the ensuing 30 days.
  • Number of exacerbations of TTP and time to first exacerbation of TTP. [ Time Frame: up to 1 month ]
    Exacerbation is defined as recurrent thrombocytopenia following a response and requiring a reinitiation of daily plasma exchange treatment after ≥ 1 day but ≤ 30 days of no plasma exchange treatment.
  • Number of subjects relapsing of TTP for maximum of 3 months and time to first relapse of TTP. [ Time Frame: up to 3 months ]
    Relapse is defined as novo event of TTP that occurs later than 30 days after the last plasma exchange.
Original Other Pre-specified Outcome Measures
 (submitted: July 15, 2019)
  • Complete remission rate [ Time Frame: up to 21 days ]
    Number of subjects with complete remission
  • Number of plasma exchange [ Time Frame: up to 21 days ]
    The number of plasma exchange to achieved remission.
  • Volume of plasma [ Time Frame: up to 21 days ]
    The volume of plasma to achieved remission.
  • Time to achieve threshold values of biological markers. [ Time Frame: up to 3 months ]
    The biological markers include platelets，LDH and creatinine.
  • Total mortality [ Time Frame: treatment period and the ensuing 30 days ]
    Total mortality within the plasma exchange treatment period and the ensuing 30 days.
  • Number of exacerbations of TTP and time to first exacerbation of TTP. [ Time Frame: up to 1 month ]
    Exacerbation is defined as recurrent thrombocytopenia following a response and requiring a reinitiation of daily plasma exchange treatment after ≥ 1 day but ≤ 30 days of no plasma exchange treatment.
  • Number of subjects relapsing of TTP for maximum of 3 months and time to first relapse of TTP. [ Time Frame: up to 3 months ]
    Relapse is defined as novo event of TTP that occurs later than 30 days after the last plasma exchange.
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)
Brief Summary This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.
Detailed Description The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma（FFP）and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acquired Thrombotic Thrombocytopenic Purpura
Intervention  ICMJE
  • Drug: Anfibatide
    5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
    Other Name: Anti-platelet thrombolysin for injection
  • Drug: Placebos
    5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
Study Arms  ICMJE
  • Experimental: Anfibatide
    Intervention: Drug: Anfibatide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebos
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2019) 		74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female and male subjects with 18 years of age or older.
  2. Subjects with diagnosis of TTP.
  3. Necessitating plasma exchange.
  4. Obtained, signed and dated informed consent.

Exclusion Criteria:

  1. Platelet count greater or equal to 100*10^9/μL.
  2. Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate <30ml/min.
  3. Uncontrolled severe active infection.
  4. Known congenital TTP.
  5. Subjects with malignant tumors in the past 5 years.
  6. Other diseases that cause microangiopathy hemolytic anemia and thrombocytopenia, such as disseminated intravascular coagulation (DIC), antiphospholipid antibody syndrome, hemolytic uremic syndrome, malignant hypertension, and transplant-related microangiopathy.
  7. Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
  8. Severe active bleeding or progressive aggravation of bleeding symptoms.
  9. Subjects who have received plasmapheresis during the treatment of the onset of the disease.
  10. Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
  11. Subject who have participated in other clinical trials related to Anfibatide.
  12. Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
  13. Life expectation less than 1 week.
  14. Known to be allergic to the drugs or ingredients in the study.
  15. Inability to follow programme requirements and procedures.
  16. Subjects who are not eligible to participate in this clinical study as determined by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Weili Zhao, MD 13512112076 zhaoweili-sih@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04021173
Other Study ID Numbers  ICMJE APT-ZK-201901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee's Pharmaceutical Limited
Study Sponsor  ICMJE Lee's Pharmaceutical Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Weili Zhao, MD Shanghai Ruijing Hospital
PRS Account Lee's Pharmaceutical Limited
Verification Date July 2019

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

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