Last updated: 08/06/2025 08:40:07
A safety study of Momelotinib in Korean participants
GSK study ID
221878
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: An open label, multi-centre, observational study to observe the safety of Omjjara administered in Korean subjects in real-world practice
Trial description: The purpose of this study is to assess the safety of Momelotinib and observe the exploratory variables when used according to its approved indications in routine clinical practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with adverse events/adverse drug reactions, unexpected adverse events/adverse drug reactions, serious adverse events/serious adverse drug reactions
Timeframe: After at least of 24 weeks of follow-up. Window period of -4 weeks is allowed considering visit schedule
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2029-30-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Primary Myelofibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to March 2029
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Treatment of intermediate-risk or high-risk myelofibrosis (including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) in adults with anemia.
- Participants with hypersensitivity to this drug or any of its components.
- This drug contains lactose and should not be administered to participants with genetic problems such as galactose intolerance, Lactase-Phlorizin Hydrolase Persistence (LAPP) lactase deficiency, or glucose-galactose malabsorption.
Inclusion and exclusion criteria
Inclusion criteria:
Treatment of intermediate-risk or high-risk myelofibrosis (including primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) in adults with anemia.
Exclusion criteria:
- This drug contains lactose and should not be administered to participants with genetic problems such as galactose intolerance, Lactase-Phlorizin Hydrolase Persistence (LAPP) lactase deficiency, or glucose-galactose malabsorption.
Participants with hypersensitivity to this drug or any of its components.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
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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