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

NCT04021173 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-07-17

No results posted yet for this study

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.

Conditions

  • Acquired Thrombotic Thrombocytopenic Purpura

Interventions

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

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • Weili Zhao, MD · Shanghai Ruijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-07-31
Completion
2021-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021173 on ClinicalTrials.gov