Last updated: 11/07/2018 11:50:30

Clinical Pharmacology Reporting and Analysis Plan for a Combined Analyses to Evaluate the Effect of Ofatumumab on Cardiac Repolarization (QTc Duration)

GSK study ID
200791
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical Pharmacology Reporting and Analysis Plan for a Combined Analyses to Evaluate the Effect of Ofatumumab on Cardiac Repolarization (QTc Duration)
Trial description: The purpose of the analyses contained in this report is to assess the potential effect of
ofatumumab on cardiac repolarization and to evaluate any relationship between
ofatumumab concentration and QT interval.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

ECG

Timeframe: Predose and post dose collections

Secondary outcomes:

plasma drug level and ECG

Timeframe: predose and post dose collections

adverse events and ECG

Timeframe: Predose and post dose collections

Interventions:
Not applicable
Enrollment:
85
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Roxanne C. Jewell, Kevin Laubscher, Eric Lewis, Lei Fang, Zarina Gafoor, Jodi Carey, Astrid McKeown, Sarah West, Oliver Wright, Donna Sedoti, Iestyn Dixon, Scott Hottenstein, and Geoffrey Chan.Assessment of the Effect of Ofatumumab on Cardiac Repolarization.J Clin Pharmacol.2015;55(1):114-121
Medical condition
Cancer, Neoplasms
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
May 2010 to September 2012
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
  • Subjects had to meet the inclusion criteria for the study they were enrolled. Multiple studies were used for data, so there are no inclusion criteria for this meta analysis.
  • Subjects had to meet the exclusion criteria for the study they were enrolled. Multiple studies were used for data, so there are no exclusion criteria for this meta analysis.
Inclusion and exclusion criteria
Inclusion criteria:
  • Subjects had to meet the inclusion criteria for the study they were enrolled. Multiple studies were used for data, so there are no inclusion criteria for this meta analysis.
Exclusion criteria:
  • Subjects had to meet the exclusion criteria for the study they were enrolled. Multiple studies were used for data, so there are no exclusion criteria for this meta analysis.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-21-09

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website