An interventional non-therapeutic study to assess ex vivo basophil activation in response to various preparations of taspoglutide

An interventional non-therapeutic study to assess ex vivo basophil activation in response to various preparations of taspoglutide and related items in blood samples from subjects who previously received taspoglutide and experienced a systemic allergic reactuin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001935-21-IT

Enrollment

Registered

2011-12-29

Start date

2011-08-30

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Diabetes MedDRA version: 14.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Taspoglutide Pharmaceutical Form: Solution for injection Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0-

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Subjects who, during one of the Roche T-Emerge Programme studies, experienced a serious or non-serious adverse event (AE) that is suggestive of a possible systemic allergic reaction to the study drug (per the Investigator's assessment). - Ability and willingness to give written informed consent and to provide a blood sample for the BAT. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

Exclusion criteria: • Subjects who participated in any other clinical study within 30 days prior to screening or who may enter another clinical study during the course of this study. • Subjects who experienced a systemic allergic reaction, during one of the Roche T-Emerge Programme Studies, more than 24 months prior to screening. • Subjects who received immunosuppressants within 1 week prior to screening. • Subjects who received any GLP-1 mimetic/analogue other than taspoglutide at any time. • Subjects who received taspoglutide since the last administration in the T-Emerge Programme.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the occurrence of positive reaction (basophil activation signal) to various taspoglutide formulations (including taspoglutide used in Phase III clinical trials, extra-pure (EP) taspoglutide, taspoglutide used in Phase II (active pharmaceutical ingredient (API) from Polypeptide Laboratories, Inc.), synthetic impurities of taspoglutide, placebo and another GLP-1 analogue (liraglutide) in blood samples of subjects who received taspoglutide in the T-Emerge Programme studies and experienced a systemic allergic reaction;Secondary Objective: None;Primary end point(s): Positive or negative reaction in BAT (Basophil Activation Test);Timepoint(s) of evaluation of this end point: The BAT is to be perfomed within 56 hours of Blood draw	—

Measure

Time frame

Main Objective: To assess the occurrence of positive reaction (basophil activation signal) to various taspoglutide formulations (including taspoglutide used in Phase III clinical trials, extra-pure (EP) taspoglutide, taspoglutide used in Phase II (active pharmaceutical ingredient (API) from Polypeptide Laboratories, Inc.), synthetic impurities of taspoglutide, placebo and another GLP-1 analogue (liraglutide) in blood samples of subjects who received taspoglutide in the T-Emerge Programme studies and experienced a systemic allergic reaction;Secondary Objective: None;Primary end point(s): Positive or negative reaction in BAT (Basophil Activation Test);Timepoint(s) of evaluation of this end point: The BAT is to be perfomed within 56 hours of Blood draw

—

Secondary

Measure	Time frame
Secondary end point(s): None	—

Countries

Brazil, Italy, United States

Contacts

Public ContactClinical Trials

Ipsen Pharma SAS

ct-application@ipsen.com+33160929480

Outcome results

None listed

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