Nicht-interventionelle Studie (Anwendungsbeobachtung) NIS-Nr.: 576
Studiencode: TH-IBA-CTR-0001
Allgemeine Angaben
| Institution: |
ROKC Research Organisation (KC) Ltd. |
Auftraggeber: |
Theratechnologies Europe Limited |
| Titel der NIS: |
A Prospective and Retrospective, Observational Multicentre Ibalizumab Study of Efficacy (PROMISE) |
| Ziel der NIS: |
Primary Objective:
To evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment vs. matched patients not receiving ibalizumab.Secondary Objective:
To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic and clinical outcomes of patients before and after they receive ibalizumab treatment.
To assess the long-term safety and tolerability of ibalizumab.
Other Objectives:
To assess risk factors/predictors of virologic and immunologic response.
|
| Ort der Durchführung: |
multinational |
|
|
| Patientenanzahl insgesamt: |
930 |
Anzahl Ärzte insgesamt: |
50 |
| Patientenanzahl in Deutschland: |
12 |
Ärzte in Deutschland: |
4 |
Weitere Angaben und Unterlagen
| Anzeige am: |
30.04.2021 |
Geplanter Beginn: |
01.06.2021 |
Geplantes Ende: |
01.06.2026 |
| Angezeigtes Ende der NIS am: 23.12.2022 |
Angaben zu den beobachteten Arzneimitteln, soweit angezeigt
| Arzneimittelbezeichnung |
INN |
Zulassungs-Nr. |
ATC-Code |
Substanzklasse |
| Trogarzo |
|
EU/1/19/1359/001 |
J05AX23 |
humanized monoclonal antibody |
Verfügbare Dokumente
| Art des Dokuments |
|
| Beobachtungsplan, NIS 576 |
pdf 515KB |