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Proteinase Inhibitor
Alpha-1 MP for Emphysema Due to AATD (SPARTA Trial)
Phase 3
Waitlist Available
Research Sponsored by Grifols Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At the Screening (Week -3) Visit, have a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% of predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II or III)
Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or 'at-risk' alleles
Must not have
Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the Screening Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase
On the waiting list for lung surgery, including lung transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 26, 52, 78, 104, 130 and 156
Awards & highlights
Summary
This trial tests if Alpha-1 MP, given through an IV drip regularly, can improve lung health in patients with lung conditions. The effectiveness will be monitored using CT scans over a long period. Alpha-1 MP is related to a therapy that has been used to reduce severe lung issues in patients.
Who is the study for?
This trial is for individuals with a specific lung condition called Alpha-1 Antitrypsin Deficiency (AATD) and related emphysema. Participants must have certain levels of lung function, documented AATD genetic variants, and evidence of emphysema. Smokers or those who've had recent alpha1-PI therapy, lung surgery, severe allergic reactions to blood products, or exacerbations of COPD are excluded.
What is being tested?
The study tests two doses (60 mg/kg and 120 mg/kg) of a drug called Alpha-1 MP against a saline placebo. Given weekly through IV for three years, the effectiveness is measured by CT scans of the lungs. The trial randomly assigns participants to receive either dose or placebo without them knowing which one they're getting.
What are the potential side effects?
While not specified here, potential side effects may include reactions at the infusion site such as pain or swelling, flu-like symptoms including fever and chills, nausea or headaches. Severe allergic reactions could occur but are less common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function test shows moderate to severe COPD.
Select...
I have a specific genetic form of AATD.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken more than a low dose of steroids in the last 5 weeks.
Select...
I am on the waiting list for lung surgery or a lung transplant.
Select...
I have had a lung or liver transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 26, 52, 78, 104, 130 and 156
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 26, 52, 78, 104, 130 and 156
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Whole lung PD15 (15th percentile point)
Secondary study objectives
Adverse Events (AEs)
Change from Baseline in PD15 of the basal lung region
Change from baseline in Saint George's Respiratory Questionnaire: Minimum value = 0, maximum value = 100, higher scores indicate worse condition
+6 moreSide effects data
From 2007 Phase 3 trial • 24 Patients • NCT002950618%
Upper respiratory tract infection
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alpha-1 MP
Prolastin
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Alpha-1 MP 60 mg/kgExperimental Treatment1 Intervention
Alpha-1 MP 60 mg/kg administered weekly by IV infusion for 156 weeks
Group II: Alpha-1 MP 120 mg/kgExperimental Treatment1 Intervention
Alpha-1 MP 120 mg/kg administered weekly by IV infusion for 156 weeks
Group III: PlaceboPlacebo Group1 Intervention
0.9% Sodium Chloride for Injection, USP, administered weekly by IV infusion for 156 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpha-1 MP
2016
Completed Phase 3
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Alpha-1 Antitrypsin Replacement Therapy, such as the one studied in the Alpha-1 MP trial, involves regular intravenous infusions of alpha-1 antitrypsin derived from human plasma. This therapy aims to increase the levels of AAT in the blood and lungs, thereby protecting lung tissue from inflammation and damage.
For patients with Alpha-1 Antitrypsin Deficiency, this treatment is essential as it helps to slow the progression of emphysema, improve lung function, and manage chronic lung damage associated with the condition.
Sorbitol Is a Severity Biomarker for PMM2-CDG with Therapeutic Implications.Recent advances in establishing a cure for GNE myopathy.[A retrospective study of six patients with late-onset Pompe disease].
Sorbitol Is a Severity Biomarker for PMM2-CDG with Therapeutic Implications.Recent advances in establishing a cure for GNE myopathy.[A retrospective study of six patients with late-onset Pompe disease].
Find a Location
Who is running the clinical trial?
Grifols Therapeutics LLCLead Sponsor
57 Previous Clinical Trials
5,463 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test shows that you have low levels of alpha1-PI.Your lung function test shows very low carbon monoxide diffusion or signs of lung damage on a recent CT scan.I have been on alpha1-PI therapy for over a month in the last six months.I have had a worsening of my COPD within the last 5 weeks.I have not had lung surgery in the last 2 years, except for a biopsy.I have smoked or used nicotine products in the last year.I haven't taken more than a low dose of steroids in the last 5 weeks.I haven't taken antibiotics for COPD flare-ups in the last 5 weeks.My lung function test shows moderate to severe COPD.My doctor has diagnosed me with emphysema.I am on the waiting list for lung surgery or a lung transplant.I have had a lung or liver transplant.You cannot physically fit inside the CT scanner, or you are mentally unable to undergo a CT scan due to feeling claustrophobic.I have a specific genetic form of AATD.You have had a serious allergic reaction to a specific type of medication or blood product in the past.I have received alpha1-PI therapy within the last month.You have a severe deficiency in Immunoglobulin A (IgA).
Research Study Groups:
This trial has the following groups:- Group 1: Alpha-1 MP 60 mg/kg
- Group 2: Alpha-1 MP 120 mg/kg
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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