During the previous study GLP973EC-179731/GLPG3067-CL-108 in which GLPG3067, GLPG2222 and GLPG2737 were administered, some volunteers developed a hypersensitivity skin reaction (rash). As this is an important event for the further development of the…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For this follow-up study, blood will be collected and this blood will be used
for a so called lymphocyte transformation test (LTT). The LTT is a useful test
for the diagnosis of drug hypersensitivity. The LTT will be done in order to
better understand the cause of these hypersensitivity skin reactions.
Secondary outcome
N/A
Background summary
GLPG3067, GLPG2222 and GLPG2737 are new compounds that may eventually be used
for the treatment of cystic fibrosis (CF). CF is a genetic disorder that causes
the body to produce unusually thick mucus. The thick mucus results in
malfunction of organs like the lungs, pancreas and liver.
Study objective
During the previous study GLP973EC-179731/GLPG3067-CL-108 in which GLPG3067,
GLPG2222 and GLPG2737 were administered, some volunteers developed a
hypersensitivity skin reaction (rash). As this is an important event for the
further development of the study compounds, the Sponsor would like to
investigate this further in a follow-up study. In this follow up study,
volunteers who developed a skin reaction will be included and . Tto be able to
fully understand the processes that lead to the skin reaction, also volunteers
that have not suffered from a skin reaction will be included.
Study design
The volunteer will be contacted by phone and will be invited to participate in
this follow-up study. This study consists of 1 visit only. Firstly, the
responsible doctor or a member of the study staff will discuss the study and
the requirements for participation in this study with you.
The volunteer can participate in this study because you have participated in
study GLP973EC 179731/GLPG3067-CL-108 before. The volunteer will however be
excluded from participation in this study if the volunteer has received another
study compound in the meantime. It is therefore important that the volunteer is
completely truthful with the responsible doctor and study staff about this.
After consenting to participate in the study (by signing and dating this
document), the following items will be reviewed for the period between the end
of study GLP973EC 179731/GLPG3067 CL-108 and the current visit:
- use of medication
- participation in another clinical study with a study compound
After that, 12 tubes of 8 milliliters of blood (96 milliliters in total) will
be taken. These blood samples will be used for in vitro testing (*test-tube
experiments*) of hypersensitivity reactions to one of the study compounds that
were given in the GLP973EC 179731/GLPG3067 CL-108 study. No other assessments
will be done.
Intervention
N/A
Study burden and risks
There is no direct benefit for the subjects from taking part in the study. The
results of the study will provide valuable information for future research.
Generaal de Wittelaan L11 A3
Mechelen 2800
BE
Generaal de Wittelaan L11 A3
Mechelen 2800
BE
Listed location countries
Age
Inclusion criteria
- trial subjects: subjects who participated in Part 4 or Part 5 of the GLPG3067 -CL -101 or the GLPG3067-CL-108 clinical trial and developed skin reactions suspected as drug hypersensitivity, OR
-control subjects: subjects who participated in Part 4 or Part 5 of the GLPG3067- CL- 101 or the GLPG3067-CL-108 clinical trial and did not develop any skin reaction or drug hypersensitivity signs.;- Able and willing to comply with the protocol requirements and to sign the ICF as approved by the Independent Ethics Committee (IEC), before any study-related procedures are performed.
Exclusion criteria
- Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65952.056.18 |