Status:
UNKNOWN
A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Acquired Thrombotic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04021173
Start Date
July 1 2019
End Date
November 1 2021
Last Update
July 17 2019
Active Locations (1)
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1
Shanghai Ruijing Hospital
Shanghai, Shanghai Municipality, China