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Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

NCT02722304 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-05-13

Study results available
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Summary

The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

BIOLOGICAL

ARALAST NP 60 mg/kg

ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy

BIOLOGICAL

ARALAST NP 120 mg/kg

ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy

BIOLOGICAL

GLASSIA 60 mg/kg

GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy

BIOLOGICAL

GLASSIA 120 mg/kg

GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy

BIOLOGICAL

Human Albumin 2%

Human albumin 2% (by appropriate dilution with normal saline solution)

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-02
Primary Completion
2018-09-14
Completion
2018-09-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

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 NCT02722304 on ClinicalTrials.gov