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Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy

NCT01737398 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2019-07-17

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).

Conditions

  • FAP
  • Familial Amyloid Polyneuropathy
  • TTR
  • Transthyretin
  • Amyloidosis

Interventions

DRUG

Inotersen

DRUG

Placebo

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-15
Primary Completion
2017-03-03
Completion
2017-11-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • France
  • Germany
  • Italy
  • New Zealand
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01737398 on ClinicalTrials.gov