CSL964_5003: Benefits of patient self-administration and Respreeza® 4g and 5g vials - an observational study

CSL964_5003: Benefits of patient self-administration and Respreeza® 4g and 5g vials - an observational study - Benefits of Respreeza self-administration

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030885

Enrollment

Registered

2022-12-08

Start date

2023-01-18

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E88.0

Interventions

Group 1: Medical staff assessment Group 2: Patient assessment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Proven diagnosis of AATD, defined as AAT serum level <11 µM (50 mg·dL-1) and/or proteinase inhibitor genotypes ZZ, SZ and compound heterozygotes or homozygotes of other rare deficient variants. - Treated with / or self-administered Respreeza® IV according to current SmPC - Understanding of the study and agreement to give written informed consent. - Able and willing to participate in the study

Exclusion criteria

Exclusion criteria: - Lack of patient consent

Design outcomes

Primary

Measure	Time frame
Primary endpoint will be the overall assessment of the treatment regime (see question 18, Appendix 17.2).	—

Secondary

Measure	Time frame
Secondary endpoints are ? Time for reconstitution and time for administration of a dose (nurse) ? Evaluation of a patient’s perceived feasibility and satisfaction of the Respreeza® self-administration home treatment	—

Countries

Germany

Contacts

Public ContactFelix; Herth;

Thoraxklinik Heidelberg;CRO Dr. med. Kottmann GmbH & Co KG

Felix.Herth@med.uni-heidelberg.de ;06221 396-1201;

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026