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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04021173 |
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Date of registration:
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15/07/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
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Scientific title:
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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) |
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Date of first enrolment:
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July 2019 |
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Target sample size:
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74 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04021173 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Weili Zhao, MD |
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Address:
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Telephone:
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13512112076 |
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Email:
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zhaoweili-sih@163.com |
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Affiliation:
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Name:
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Weili Zhao, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai Ruijing Hospital |
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Name:
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Weili Zhao, MD |
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Address:
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Telephone:
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13512112076 |
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Email:
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zhaoweili-sih@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acquired Thrombotic Thrombocytopenic Purpura
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Intervention(s)
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Drug: Anfibatide
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Drug: Placebos
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Primary Outcome(s)
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Time to response of treatment
[Time Frame: up to 21days]
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Secondary Outcome(s)
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Remission rate
[Time Frame: up to 21days]
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Secondary ID(s)
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APT-ZK-201901
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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