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IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients

NCT02854059 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-09-13

Study results available
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Summary

The main purpose of this study is to evaluate safety and tolerability in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single intravenous dose of IdeS.

Conditions

  • Purpura, Thrombotic Thrombocytopenic

Interventions

BIOLOGICAL

IdeS (0.25 mg/kg)

Single i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of efficacy and safety in the first 3 patients the dose may be increased in the following 3 patients to 0.5 mg/kg.

BIOLOGICAL

IdeS (0.50 mg/kg)

Single i.v. infusion of IdeS (0.50 mg/kg).

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • Hansa Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Sonesson, PhD · Hansa Biopharma AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United Kingdom

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 NCT02854059 on ClinicalTrials.gov