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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anfibatide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anfibatide | Drug | 5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to response of treatment | Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l | up to 21days |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate | Number of subjects with remission | up to 21days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Number of subjects with complete remission | up to 21 days |
| Number of plasma exchange | The number of plasma exchange to achieved remission. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, MD | Contact | 13512112076 | zhaoweili-sih@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao, MD | Shanghai Ruijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijing Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D011697 | Purpura, Thrombotic Thrombocytopenic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C000592236 | agkisacucetin protein, Agkistrodon acutus |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebos | Drug | 5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion |
|
| up to 21 days |
| Volume of plasma | The volume of plasma to achieved remission. | up to 21 days |
| Time to achieve threshold values of biological markers. | The biological markers include platelets,LDH and creatinine. | up to 3 months |
| Total mortality | Total mortality within the plasma exchange treatment period and the ensuing 30 days. | up to 21days and the ensuing 30 days |
| Number of exacerbations of TTP and time to first exacerbation of TTP. | 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. | up to 1 month |
| Number of subjects relapsing of TTP for maximum of 3 months and time to first relapse of TTP. | Relapse is defined as novo event of TTP that occurs later than 30 days after the last plasma exchange. | up to 3 months |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D019851 | Thrombophilia |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |