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 GSK Clinical Study Register is no longer maintained for this study.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
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    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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