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Protein Replacement Therapy

Zemaira® for CPFE Syndrome

Phase 4
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over a 2-year period
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

This is a randomized, placebo-controlled, double-blind, multicenter phase III/IV study to compare the efficacy and safety of Zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The effect of Zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (CT).

Eligible Conditions
  • CPFE Syndrome
  • Emphysema
  • Alpha-1 Antitrypsin Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over a 2-year period
This trial's timeline: 3 weeks for screening, Varies for treatment, and over a 2-year period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annual Rate of Change in Lung Density
Secondary study objectives
Annual Rate of Pulmonary Exacerbations
Change in Exercise Capacity
Change in Lung Density
+9 more

Side effects data

From 2012 Phase 4 trial • 180 Patients • NCT00261833
41%
Headache
32%
Nasopharyngitis
29%
Chronic obstructive pulmonary disease
24%
Oropharyngeal pain
23%
Cough
22%
Condition aggravated
19%
Lower respiratory tract infection
17%
Dyspnoea
16%
Upper respiratory tract infection
15%
Nausea
15%
Influenza
13%
Sinusitis
13%
Bronchitis
13%
Pyrexia
12%
Back pain
10%
Abdominal pain upper
9%
Pneumonia
9%
Fatigue
9%
Diarrhoea
9%
Urinary tract infection
8%
Rhinitis
8%
Muscle spasms
6%
Oedema peripheral
6%
Dizziness
6%
Arthralgia
6%
Gastritis
6%
Hypertension
5%
Chest pain
5%
Vomiting
5%
Musculoskeletal pain
5%
Pain in extremity
5%
Toothache
5%
Gastrooesophageal reflux disease
5%
Anxiety
4%
Influenza like illness
4%
Gastroenteritis
4%
Pharyngitis
2%
Pneumothorax
2%
Lung neoplasm
2%
Abdominal discomfort
1%
Anaphylactic reaction
1%
Pulmonary embolism
1%
Respiratory failure
1%
Bladder cancer
1%
Gastroenteritis viral
1%
Abdominal pain
1%
Gastroesophageal reflux disease
1%
Ileus
1%
Small intestinal obstruction
1%
Transurethral prostatectomy
1%
Angina pectoris
1%
Post procedural haemorrhage
1%
Confusional state
1%
Suicide attempt
1%
Hydronephrosis
1%
Hypotension
1%
Respiratory tract infection
1%
Tooth abscess
1%
Hyponatraemia
1%
Adhesion
1%
Diverticulitis
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zemaira®
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zemaira®Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpha-1-proteinase inhibitor
FDA approved

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
198 Previous Clinical Trials
1,204,641 Total Patients Enrolled
Senior Director Immonology & Pulmonology, Clinical R&DStudy DirectorCSL Behring
~9 spots leftby Nov 2025
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