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End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 3/15/21 - 1 form, 4 itemgroups, 32 items, 2 languages
Itemgroups: Medications, Adverse Events, Transfusion history during the entry study, Conclusion of the Study and Termination
Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Day 7

- 11/6/18 - 1 form, 5 itemgroups, 19 items, 1 language
Itemgroups: Vital Signs, Capillary Blood Glucose measurement, Antidiabetics; Tolerability Study, Adverse event, Antidiabetics; Tolerability Study; Worksheet
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Serious Adverse Events

- 10/12/18 - 1 form, 11 itemgroups, 39 items, 1 language
Itemgroups: Non-Serious Adverse Event, Serious Adverse Event; Seriousness of Adverse Event, Serious Adverse Event; Demographics Domain, Serious Adverse Event; Recurrence; Investigational New Drugs; Other, Serious Adverse Event; Cause, Serious Adverse Event; Medical History, Serious Adverse Events; Risk Factors, Serious Adverse Event; Concomitant Agent, Serious Adverse Events; Experimental Drugs, Serious Adverse Events; Evaluation, Serious Adverse Event; Comment
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Non-Serious Adverse Events

- 10/9/18 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: Non-Serious Adverse Event
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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