Drug Use Investigation for Arzerra Chronic Lymphocytic Leukemia (CLL) (116789)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48996
• EU PAS number:
  EUPAS10093
• Study ID:
  48996
• Official title and acronym:
  Drug Use Investigation for Arzerra Chronic Lymphocytic Leukemia (CLL) (116789)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This investigation will be conducted to collect and evaluate information regarding the safety and efficacy of Arzerra under the actual post-marketing use conditions of the product.
• Study status:
  Finalised

Research institution and networks

Institutions

Novartis Pharmaceuticals

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/12/2012

Actual: 25/12/2012

Study start date

Planned: 31/07/2013

Actual: 30/07/2013

Data analysis start date

Planned: 30/06/2022

Actual: 05/04/2022

Date of final study report

Planned: 15/11/2022

Actual: 14/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

gsk-116789-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

COMB157A1401