NCT04021173

A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Thrombotic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	Anfibatide	5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
DRUG	Placebos	5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-07-01
• Completion: 2021-11-01
• First posted: 2019-07-16
• Last updated: 2019-07-17

Locations

1 site across 1 country: China