Study on Long-term Safety of Weekly Intravenous Alpha-1-Proteinase Inhibitor for Patients with Pulmonary Emphysema Due to Alpha-1-Antitrypsin Deficiency

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What is this study about?

This clinical trial is focused on studying the long-term safety of a treatment for people with a specific type of lung disease called Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency. This condition is a genetic disorder that can lead to lung damage. The treatment being tested is called Alpha-1-Proteinase Inhibitor (Human), which is given as a weekly injection into a vein. The purpose of the study is to gather more information about the safety of this treatment over an extended period.

Participants in the study will receive the treatment once a week for up to two years. During this time, researchers will monitor the participants’ health to ensure the treatment is safe. The study will involve regular check-ups and assessments to track any changes in the participants’ condition and to identify any potential side effects. The goal is to ensure that the treatment is safe for long-term use in people with this type of lung disease.

Throughout the study, various health measurements will be taken, such as lung function tests and questionnaires about respiratory health. These assessments will help researchers understand how the treatment affects the participants’ lung health and overall well-being. The study aims to provide valuable information that could lead to improved treatment options for individuals with Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency.

1 joining the study

Participation begins after completing a previous study or experiencing a specific decline in lung function.

Informed consent is required to proceed.

2 treatment administration

Receive a weekly intravenous dose of alpha-1-proteinase inhibitor (human).

The dosage is 60 mg per kg of body weight.

3 monitoring and assessments

Regular assessments include lung imaging and tests to measure lung function.

Questionnaires evaluate respiratory health and quality of life.

4 safety evaluations

Monitor for any adverse effects or serious adverse effects.

Regular physical examinations and laboratory tests are conducted.

5 study duration

The study aims to collect data over an additional two years.

The estimated end date for the study is October 1, 2028.

Who Can Join the Study?

The patient must have completed participation in a previous study called GTi1201, which means they finished the Week 156 and Week 160/End-of-Study Visit.
Alternatively, the patient must have experienced a decline in their lung function, measured by a test called FEV1, at a rate of at least 134.4 mL per year after the Week 104 Visit in the GTi1201 study. FEV1 is a test that measures how much air a person can forcefully exhale in one second.
The patient must be willing and able to provide informed consent, which means they agree to participate in the study after understanding all the details and risks involved.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population, meaning they may need extra protection or care.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medication.
Patients with other serious lung diseases that are not related to Alpha-1-Antitrypsin Deficiency.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse within the past year.
Patients who have had a major surgery within the last 3 months.
Patients with uncontrolled high blood pressure or heart disease.
Patients with active infections that require treatment with antibiotics.
Patients who have been diagnosed with cancer in the past 5 years, except for certain types of skin cancer.
Patients who have received a blood transfusion in the last 3 months.
Patients with liver disease that is not related to Alpha-1-Antitrypsin Deficiency.
Patients who have a history of mental health disorders that are not well controlled.
Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Turku University Hospital	Turku	Finland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
North Estonia Medical Centre Foundation	Tallin	Estonia
Nnirbabf Ibkwtrsav Op Tltmgzacyxsd Asl Ltsl Dbkjudpr	Warsaw	Poland
Auxehc Ufabrgzyqa Hnidfajk	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	30.08.2016
Estonia	Not recruiting	30.08.2016
Finland	Recruiting	30.08.2016
France	Not recruiting	30.08.2016
Poland	Recruiting	30.08.2016
Sweden	Recruiting	30.08.2016

Trial locations

Alpha-1 Proteinase Inhibitor (Human), Modified Process is a medication used in this study to treat patients with pulmonary emphysema caused by Alpha-1 Antitrypsin Deficiency (AATD). It is given through an intravenous infusion once a week. The purpose of this medication in the trial is to gather more safety information over a two-year period for patients receiving this treatment.

Pulmonary Emphysema due to Alpha-1-Antitrypsin Deficiency – This is a lung condition that occurs when the body lacks a protein called alpha-1-antitrypsin, which protects the lungs from damage. Without enough of this protein, the lungs can become damaged over time, leading to emphysema. Emphysema is characterized by the destruction of the air sacs in the lungs, which reduces the surface area available for gas exchange. As the disease progresses, individuals may experience difficulty breathing, especially during physical activity. The condition can lead to chronic obstructive pulmonary disease (COPD), where airflow is obstructed, making it hard to breathe. Symptoms often include shortness of breath, wheezing, and a chronic cough.

Trial ID:

2024-513962-20-00

Protocol code:

GTi1201_OLE

NCT ID:

NCT02796937

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety of Weekly Intravenous Alpha-1-Proteinase Inhibitor for Patients with Pulmonary Emphysema Due to Alpha-1-Antitrypsin Deficiency

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?