Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a continuation of the placebo-controlled study CE1226\_4001 (NCT00261833) to evaluate the efficacy and safety of Zemaira® intravenous (i.v). administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term verification of a disease-modifying benefit of Zemaira® on the progression of emphysema will be assessed by volume-adjusted lung density, measured yearly by computed tomography (CT).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

NCT00261833

Alpha1-proteinase Inhibitor Deficiency Emphysema

COMPLETED PHASE4

Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)

NCT07326592

Alpha1 Antitrypsin Deficiency Alpha1-Proteinase Inhibitor Deficiency Emphysema

NOT_YET_RECRUITING PHASE4

Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

NCT05856331

Alpha 1-Antitrypsin Deficiency Emphysema

COMPLETED PHASE2

A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema

NCT05466747

Chronic Obstructive Pulmonary Disease (COPD) Alpha1-Antitrypsin Deficiency

WITHDRAWN PHASE4

Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest

NCT02989168

Idiopathic Pulmonary Fibrosis Hypoxemia

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emphysema Alpha 1-proteinase Inhibitor Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zemaira®

Group Type EXPERIMENTAL

Alpha1- proteinase inhibitor [human]

Intervention Type BIOLOGICAL

Lyophilized preparation of 60 mg/kg body weight intravenously once per week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alpha1- proteinase inhibitor [human]

Lyophilized preparation of 60 mg/kg body weight intravenously once per week

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zemaira® Respreeza®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who have completed the 2-year treatment and observation period in the Phase 3/4 Zemaira® CE1226\_4001 study (NCT00261833) and are willing to sign informed consent
* Males, and non-pregnant, non-lactating females, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator

Exclusion Criteria

* Individuals residing in the US
* Current evidence of alcohol abuse or abuse of drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids
* History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol
* Current tobacco smoker (smoking must be discontinued for at least 6 months prior to study participation)
* Conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator
* History of non-compliance
* Administration of any other experimental new drug or participation in an investigation of a marketed product
* Inability to perform necessary study procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No