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

- 06/11/18 - 1 modulo, 5 itemgroups, 17 elementi, 1 linguaggio
Itemgroups: Vital Signs, 12 lead ECG, Clinical Chemistry, Hematology finding, Urinalysis
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 - Day 21

- 09/10/18 - 1 modulo, 3 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Fructosamine measurement, Immunogenicity Study; Blood, Pharmacokinetic aspects; Blood
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

Follow Up - Visit 20 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/16 - 1 modulo, 5 itemgroups, 26 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
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

Follow Up - Visit 19 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/16 - 1 modulo, 5 itemgroups, 26 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
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

Follow Up - Visit 18 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/16 - 1 modulo, 5 itemgroups, 26 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
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

Follow Up - Visit 21 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 01/11/16 - 1 modulo, 5 itemgroups, 26 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Signature principal investigator
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

Maintenance Period - Visit 9 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 25/10/16 - 1 modulo, 6 itemgroups, 31 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Study medication, Signature principal investigator
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

Maintenance Period - Visit 10 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 25/10/16 - 1 modulo, 8 itemgroups, 34 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Six-Minute Walk Test, Weight, Circulatory Symptoms, Study medication, Signature principal investigator
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

Early Termination Visit - Visit 17 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 25/10/16 - 1 modulo, 9 itemgroups, 37 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Weight, Vital signs, Examinations, Six-Minute Walk Test, Circulatory Symptoms, Study medication, Signature principal investigator
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

Maintenance Period - Visit 13 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 25/10/16 - 1 modulo, 6 itemgroups, 31 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Study medication, Signature principal investigator
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

Maintenance Period - Visit 11 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 25/10/16 - 1 modulo, 6 itemgroups, 31 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Study medication, Signature principal investigator
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

Maintenance Period - Visit 15 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 25/10/16 - 1 modulo, 6 itemgroups, 31 elementi, 2 lingue
Itemgroups: Date of Visit, LDH, Vital signs, Circulatory Symptoms, Study medication, Signature principal investigator
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

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