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)
Overview
- Phase
- Phase 2
- Intervention
- Anfibatide
- Conditions
- Acquired Thrombotic Thrombocytopenic Purpura
- Sponsor
- Lee's Pharmaceutical Limited
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Time to response of treatment
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Anfibatide
Intervention: Anfibatide
Placebo
Intervention: Placebos
Outcomes
Primary Outcomes
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 Outcomes
- Remission rate(up to 21days)