Training for doctors in injections that are delivered directly into the lymph nodes.

Training in intralymphatically injection technique. A realistic learning study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004031-40-DK

Enrollment

240

Registered

2015-03-03

Start date

2015-04-30

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

allergic rhino-conjunctivitis MedDRA version: 18.0 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Alutard SQ phleum pratense (ALK 225) Product Name: ALK 225, Alutard SQ phleum pratense Product Code: V04CL Pharmaceutical Form: Solution for injection INN or Proposed INN: grass pollen ex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: History of seasonal rhino-conjunctivitis during the grass pollen season. Positive skin prick test for grass pollen extract. Informed consent given. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Severe comorbidity. Uncontrolled asthma bronchiale. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: We would like to examine how the new treatment with intralymphatically injections can be learned by doctors with no previous experience in the treatment.;Secondary Objective: How many injections must be given before the doctor achieves stable and successful performance.;Primary end point(s): Number of injections the doctor must perform before stable and successful performance is achieved. ;Timepoint(s) of evaluation of this end point: 1 year.	—

Measure

Time frame

Main Objective: We would like to examine how the new treatment with intralymphatically injections can be learned by doctors with no previous experience in the treatment.;Secondary Objective: How many injections must be given before the doctor achieves stable and successful performance.;Primary end point(s): Number of injections the doctor must perform before stable and successful performance is achieved. ;Timepoint(s) of evaluation of this end point: 1 year.

—

Secondary

Measure	Time frame
Secondary end point(s): Clinical efficacy of treatment.;Timepoint(s) of evaluation of this end point: 1 year	—

Countries

Denmark

Contacts

Public ContactILIT Læringsstudie

Department of Respiratory Diseases, Aarhus University Hospital

hans.jurgen.hoffmann@ki.au.dk00457846 2106

Outcome results

None listed

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