Last updated: 11/03/2018 19:34:12
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
Drug Use Investigation for ARZERRA® Chronic Lymphocytic Leukemia (CLL)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Drug Use Investigation for ARZERRA® Chronic Lymphocytic Leukemia (CLL)
Trial description: This is a post-marketing surveillance (PMS) study conducted in Japan. The study aims to collect the safety and effectiveness information of ofatumumab in clinical practice and identify the status of occurrence of adverse drug reactions (ADRs) and factors affecting the safety and effectiveness.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of ADRs
Timeframe: 3 months
Secondary outcomes:
Not applicable
Interventions:
Drug: ofatumumab
Enrollment:
300
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Leukaemia, Lymphocytic, Chronic
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
July 2013 to March 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients with relapsed or refractory CD20-positive CLL
- Patients treated with ofatumumab
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with relapsed or refractory CD20-positive CLL
- Patients treated with ofatumumab
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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