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First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

NCT01191372 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-05-05

No results posted yet for this study

Summary

The purpose of this study is to examine the safety, tolerability and the way the body handles various single and multiple doses of ARC19499 in patients with hemophilia.

Conditions

Interventions

DRUG

placebo control

sterile saline for injection

DRUG

ARC19499

Anti-tissue factor pathway inhibitor (TFPI) aptamer

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-15
Primary Completion
2011-12-28
Completion
2011-12-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01191372 on ClinicalTrials.gov