← Back to Search

Proteinase Inhibitor

Alpha-1 MP for Emphysema Due to AATD (SPARTA Trial)

Q: Is this the only experiment of its kind that uses Alpha-1 MP?

Right now, there are 5 ongoing studies investigating Alpha-1 MP. Out of those, 3 are in Phase 3. Usually, the majority of trials for this medication take place in Portland, <a href="https://www.withpower.com/clinical-trials/oregon">Oregon</a>; however, at the moment there are 84 different locations running these sorts of tests.

Q: Am I eligible to participate in this research?

This medical study is looking for 339 participants who currently have alpha 1-antitrypsin deficiency and fall within the ages of 18 and 70. In addition, it is important that potential participants meet the following criteria: evidence of pulmonary <a href="https://www.withpower.com/clinical-trials/emphysema">emphysema</a> per the Investigator's judgment, post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and &#x3C; 80% of predicted and FEV1/forced vital capacity (FVC) &#x3C; 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II or III), carbon monoxide diffusing

Q: Have there been other similar trials like this one in the past?

Since 2013, when the first study was completed, there has been growing interest in Alpha-1 MP. Grifols Therapeutics LLC conducted the initial research trial in 2013 with 339 participants. The success of this Phase 3 drug approval led to 5 more live trials across 34 cities and 17 countries.

Q: Does this research include elderly individuals as participants?

In order to be qualified for this trial, participants must between 18-70 years old.

Q: Is this clinical trial available in many different places within the city?

To make things as convenient as possible for potential participants, the 8 recruitment sites for this study are located in cities across North America. If you choose to enroll, please try and select the site closest to your home to minimize travel demands.

Q: How does Alpha-1 MP affect patients who take it?

There is available evidence that suggests Alpha-1 MP is safe for use, as it has been studied in Phase 3 trials. This means that not only is there data supporting its efficacy, but also multiple rounds of data affirming its safety.

Q: Are people still signing up to participate in this experiment?

From what is detailed on clinicaltrials.gov, this trial is still recruiting patients. The earliest date that information about the trial was posted was November 1st, 2013 and there have been edits as recently as November 16th, 2020.

Q: How many individuals are enrolled in this clinical trial?

In order to carry out this research, a total of 339 individuals who meet the study's requirements are needed. The sponsor - Grifols Therapeutics LLC - will be managing the trial from multiple sites, such as Medical University of <a href="https://www.withpower.com/clinical-trials/south-carolina">South carolina</a> in Charleston and Queen Elizabeth II Health Sciences Centre in Halifax.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 26, 52, 78, 104, 130 and 156

Awards & highlights

SPARTA Trial Summary

This trial is testing whether a drug called Alpha-1 MP is effective and safe for treating people with a disease called 3-year CT of the lungs. The study will last for 156 weeks and will involve two different dose regimens of the drug.

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.Check my eligibility

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.See study design

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.

SPARTA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung function test shows moderate to severe COPD.

Select...

I have a specific genetic form of AATD.

SPARTA Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 26, 52, 78, 104, 130 and 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Whole lung PD15 (15th percentile point)

Secondary outcome measures

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 more

Side effects data

From 2007 Phase 3 trial • 24 Patients • NCT00295061

Upper respiratory tract infection

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Alpha-1 MP

Prolastin

SPARTA 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Grifols Therapeutics LLCLead Sponsor

57 Previous Clinical Trials

5,463 Total Patients Enrolled

Media Library

Alpha-1 MP (Proteinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01983241 — Phase 3

Alpha-1 Antitrypsin Deficiency Research Study Groups: Alpha-1 MP 60 mg/kg, Alpha-1 MP 120 mg/kg, Placebo

Alpha-1 Antitrypsin Deficiency Clinical Trial 2023: Alpha-1 MP Highlights & Side Effects. Trial Name: NCT01983241 — Phase 3

Alpha-1 MP (Proteinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01983241 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the only experiment of its kind that uses Alpha-1 MP?

"Right now, there are 5 ongoing studies investigating Alpha-1 MP. Out of those, 3 are in Phase 3. Usually, the majority of trials for this medication take place in Portland, Oregon; however, at the moment there are 84 different locations running these sorts of tests."

Answered by AI

Am I eligible to participate in this research?

"This medical study is looking for 339 participants who currently have alpha 1-antitrypsin deficiency and fall within the ages of 18 and 70. In addition, it is important that potential participants meet the following criteria: evidence of pulmonary emphysema per the Investigator's judgment, 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), carbon monoxide diffusing"

Answered by AI

Have there been other similar trials like this one in the past?

"Since 2013, when the first study was completed, there has been growing interest in Alpha-1 MP. Grifols Therapeutics LLC conducted the initial research trial in 2013 with 339 participants. The success of this Phase 3 drug approval led to 5 more live trials across 34 cities and 17 countries."

Answered by AI

Does this research include elderly individuals as participants?

"In order to be qualified for this trial, participants must between 18-70 years old."

Answered by AI

Is this clinical trial available in many different places within the city?

"To make things as convenient as possible for potential participants, the 8 recruitment sites for this study are located in cities across North America. If you choose to enroll, please try and select the site closest to your home to minimize travel demands."

Answered by AI

How does Alpha-1 MP affect patients who take it?

"There is available evidence that suggests Alpha-1 MP is safe for use, as it has been studied in Phase 3 trials. This means that not only is there data supporting its efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

Are people still signing up to participate in this experiment?

"From what is detailed on clinicaltrials.gov, this trial is still recruiting patients. The earliest date that information about the trial was posted was November 1st, 2013 and there have been edits as recently as November 16th, 2020."

Answered by AI

How many individuals are enrolled in this clinical trial?

"In order to carry out this research, a total of 339 individuals who meet the study's requirements are needed. The sponsor - Grifols Therapeutics LLC - will be managing the trial from multiple sites, such as Medical University of South carolina in Charleston and Queen Elizabeth II Health Sciences Centre in Halifax."

Answered by AI

Recent research and studies

Respiratory MedicineJournal

SPARTA Clinical Trial Design: Exploring the Efficacy and Safety of Two Dose Regimens of Alpha1-proteinase Inhibitor Augmentation Therapy in Alpha1-antitrypsin Deficiency

Sorrells, Susan, Sandra Camprubi, Rhonda Griffin, Junliang Chen, and Jaume Ayguasanosa. 2015. “SPARTA Clinical Trial Design: Exploring the Efficacy and Safety of Two Dose Regimens of Alpha1-proteinase Inhibitor Augmentation Therapy in Alpha1-antitrypsin Deficiency”. Respiratory Medicine. Elsevier BV. doi:10.1016/j.rmed.2015.01.022.

clinicaltrials.govStudy

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

2013. "Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01983241.

All > Arizona > Emphysema