Back to resultsA Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
Primary Purpose
Acquired Thrombotic Thrombocytopenic Purpura
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anfibatide
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Thrombotic Thrombocytopenic Purpura
Eligibility Criteria
Inclusion Criteria:
- Female and male subjects with 18 years of age or older.
- Subjects with diagnosis of TTP.
- Necessitating plasma exchange.
- Obtained, signed and dated informed consent.
Exclusion Criteria:
- Platelet count greater or equal to 100*10^9/μL.
- Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate <30ml/min.
- Uncontrolled severe active infection.
- Known congenital TTP.
- Subjects with malignant tumors in the past 5 years.
- 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.
- Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
- Severe active bleeding or progressive aggravation of bleeding symptoms.
- Subjects who have received plasmapheresis during the treatment of the onset of the disease.
- Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
- Subject who have participated in other clinical trials related to Anfibatide.
- Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
- Life expectation less than 1 week.
- Known to be allergic to the drugs or ingredients in the study.
- Inability to follow programme requirements and procedures.
- Subjects who are not eligible to participate in this clinical study as determined by the investigator.
Sites / Locations
- Shanghai Ruijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Anfibatide
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time to response of treatment
Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l
Secondary Outcome Measures
Remission rate
Number of subjects with remission
Full Information
NCT ID
NCT04021173
First Posted
July 15, 2019
Last Updated
July 15, 2019
Sponsor
Lee's Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT04021173
Brief Title
A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Thrombotic Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anfibatide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Anfibatide
Other Intervention Name(s)
Anti-platelet thrombolysin for injection
Intervention Description
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
Primary Outcome Measure Information:
Title
Time to response of treatment
Description
Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l
Time Frame
up to 21days
Secondary Outcome Measure Information:
Title
Remission rate
Description
Number of subjects with remission
Time Frame
up to 21days
Other Pre-specified Outcome Measures:
Title
Complete remission rate
Description
Number of subjects with complete remission
Time Frame
up to 21 days
Title
Number of plasma exchange
Description
The number of plasma exchange to achieved remission.
Time Frame
up to 21 days
Title
Volume of plasma
Description
The volume of plasma to achieved remission.
Time Frame
up to 21 days
Title
Time to achieve threshold values of biological markers.
Description
The biological markers include platelets，LDH and creatinine.
Time Frame
up to 3 months
Title
Total mortality
Description
Total mortality within the plasma exchange treatment period and the ensuing 30 days.
Time Frame
up to 21days and the ensuing 30 days
Title
Number of exacerbations of TTP and time to first exacerbation of TTP.
Description
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.
Time Frame
up to 1 month
Title
Number of subjects relapsing of TTP for maximum of 3 months and time to first relapse of TTP.
Description
Relapse is defined as novo event of TTP that occurs later than 30 days after the last plasma exchange.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and male subjects with 18 years of age or older.
Subjects with diagnosis of TTP.
Necessitating plasma exchange.
Obtained, signed and dated informed consent.
Exclusion Criteria:
Platelet count greater or equal to 100*10^9/μL.
Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate <30ml/min.
Uncontrolled severe active infection.
Known congenital TTP.
Subjects with malignant tumors in the past 5 years.
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.
Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
Severe active bleeding or progressive aggravation of bleeding symptoms.
Subjects who have received plasmapheresis during the treatment of the onset of the disease.
Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
Subject who have participated in other clinical trials related to Anfibatide.
Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
Life expectation less than 1 week.
Known to be allergic to the drugs or ingredients in the study.
Inability to follow programme requirements and procedures.
Subjects who are not eligible to participate in this clinical study as determined by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, MD
Phone
13512112076
Email
zhaoweili-sih@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD
Organizational Affiliation
Shanghai Ruijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ruijing Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD
Phone
13512112076
Email
zhaoweili-sih@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
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