Last updated: 11/03/2018 20:48:28
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
Registry of subjects treated with Eltrombopag in Mexico
GSK study ID
200314
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: Registry of subjects treated with Eltrombopag in Mexico
Trial description: This is an observational registry database of subjects who have received/are receiving treatment with Eltrombopag to establish an intensive Pharmacovigilance program as part of a risk management plan. The aim of the registry is to identify suspected adverse drug reactions (SADRs) following Eltrombopag administration in Mexican subjects. Participating physician are to report real-world subject data about their subjects taking Eltrombopag (ITP-HCV). Data generated in this registry will be used to determine the frequency of SADR, try to identify predisposing factors and drug use patterns among others. Investigators will register retrospectively and prospectively SADRs (non-serious and serious) of the subjects who had or have been treated with Eltrombopag. Upon enrolment of subject into the registry, it would be intended to follow the subjects as long as they are on eltrombopag and information is available. The total duration of the register will be two years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Incidence and frequency of SADRs (non-serious and serious)
Timeframe: Approximately up to 2 years
Incidence and frequency of Treatment-emergent SADRs
Timeframe: Approximately up to 2 years
Number of treatment interruptions with reasons
Timeframe: Approximately up to 2 years
Secondary outcomes:
The occurrence and severity of bleeding, measured using the WHO Bleeding Scale
Timeframe: Approximately assessed up to 2 year
Number of Subjects with platelets count >50 x10^9/Liter
Timeframe: Approximately assessed up to 2 year
Number of Subjects with >400 x10^9/Liter at least once
Timeframe: Approximately assessed up to 2 year
Interventions:
Drug: Eltrombopag
Enrollment:
80
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Hepatitis C, Chronic, Purpura, Thrombocytopenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
June 2014 to July 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Males or females
- Any age
- Patients should be retired of the registry in the case of withdrawal of informed consent
- A subject may voluntarily withdraw from the registry at any time he or she chooses. If the subject withdraws consent, no further registration should be performed and no attempts should be made to collect additional data. The investigator may decide, at any time, to withdraw a subject for reasons related or unrelated to the study product or study
Inclusion and exclusion criteria
Inclusion criteria:
- Males or females
- Any age
- Subjects who are receiving Eltrombopag
- Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent. Subjects under the legal age of consent in the state where the study is conducted must provide assent and have the written, informed consent of a parent or guardian
Exclusion criteria:
- Patients should be retired of the registry in the case of withdrawal of informed consent
- A subject may voluntarily withdraw from the registry at any time he or she chooses. If the subject withdraws consent, no further registration should be performed and no attempts should be made to collect additional data. The investigator may decide, at any time, to withdraw a subject for reasons related or unrelated to the study product or study
- Subjects unwilling to participate in the study will not be included
- Those patients presenting drug or formula component hypersensitivity, persons with severe liver failure
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
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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