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Safety and clinical parameter assessment of self-infusion therapy with Prolastin® in patients with severe AATD
EU CTIS ID: 2024-515894-80-00
What this study is testing
To assess the safety of self-infusion therapy with Prolastin® in patients with severe AATD
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent obtained prior to any study-related procedure
- At least 18 years of age
- Able to understand and read German at a level sufficient to comprehend patient documents, including the informed consent, instruction materials and questionnaires. Note: Assistance for any required writing tasks can be provided by the caregiver.
- A documented diagnosis of severe Alpha-1 Antitrypsin Deficiency
- Treatment with Prolastin® for at least 3 months with documented good treatment tolerability
- Ability and willingness to learn self-infusion and perform infusions at home or being accompanied by a third person (i.e. caregiver), who has the ability and willingness to learn and perform infusions without HCP supervision (after appropriate training). Note: For patients requiring a caregiver, the availability of a suitable caregiver must be ensured in order to be eligible for inclusion. For patients who perform the self-infusion themselves, the availability of an emergency contact, i.e. a person who is willing and able to be present and monitor the patient during every self-infusion throughout the main study period, must be ensured in order to be eligible for inclusion.
You likely can't join if
- Contraindications as listed in the current SmPC: a) Individuals with selective immunoglobulin A (IgA) deficiency b) Known hypersensitivity against human Alpha-1 Proteinase Inhibitor or to any of the other ingredients in the formulation or component of the container
- Occurrence of serious adverse drug reactions due to Prolastin® infusion in the last 3 months prior to V0
- Patients who have undergone lung transplantation
- Current smokers
- Patients with venous access via port
- Participation in another clinical study with investigational medicinal product within the last 3 months prior to baseline visit or simultaneous participation in another clinical study
See the full eligibility criteria
Who can join
- Signed written informed consent obtained prior to any study-related procedure
- At least 18 years of age
- Able to understand and read German at a level sufficient to comprehend patient documents, including the informed consent, instruction materials and questionnaires. Note: Assistance for any required writing tasks can be provided by the caregiver.
- A documented diagnosis of severe Alpha-1 Antitrypsin Deficiency
- Treatment with Prolastin® for at least 3 months with documented good treatment tolerability
- Ability and willingness to learn self-infusion and perform infusions at home or being accompanied by a third person (i.e. caregiver), who has the ability and willingness to learn and perform infusions without HCP supervision (after appropriate training). Note: For patients requiring a caregiver, the availability of a suitable caregiver must be ensured in order to be eligible for inclusion. For patients who perform the self-infusion themselves, the availability of an emergency contact, i.e. a person who is willing and able to be present and monitor the patient during every self-infusion throughout the main study period, must be ensured in order to be eligible for inclusion.
- Having access to and being able to use (incl. reading and typing) a functional electronic device that enables phone calls and video calls (for remote calls from the study site or home-care study nurses) and access to an internet browser (for completion of the questionnaires)
- Suitable veins for venepuncture, according to the investigator’s discretion
- Life expectancy of over 3 years
What rules you out
- Contraindications as listed in the current SmPC: a) Individuals with selective immunoglobulin A (IgA) deficiency b) Known hypersensitivity against human Alpha-1 Proteinase Inhibitor or to any of the other ingredients in the formulation or component of the container
- Occurrence of serious adverse drug reactions due to Prolastin® infusion in the last 3 months prior to V0
- Patients who have undergone lung transplantation
- Current smokers
- Patients with venous access via port
- Participation in another clinical study with investigational medicinal product within the last 3 months prior to baseline visit or simultaneous participation in another clinical study
- Patients with psychiatric illnesses, imprisoned persons, persons admitted to nursing homes, persons under legal guardianship and persons not able to express their consent (e.g. due to mental impairment)
- Breastfeeding or pregnant women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.