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Clinical Study of ART-123 for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis

NCT02739165 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-01-18

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.

Conditions

Interventions

DRUG

ART-123

380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy

DRUG

Placebo

Placebo by intravenous drip infusion in addition to standard of care steroid therapy

Sponsors & Collaborators

  • Asahi Kasei Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Asahi Kasei Pharma Corporation · Asahi Kasei Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Japan

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 NCT02739165 on ClinicalTrials.gov