Last updated: 09/12/2023 06:50:59

An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of VOLIBRIS in Korean subjects in usual practicePMS in PAH

GSK study ID
204740
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: An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of VOLIBRIS in Korean subjects in usual practice
Trial description: Ambrisentan (VOLIBRIS; a trademark of Gilead Sciences, Inc,. that GSK uses under license) is used in treatment of Pulmonary Arterial Hypertension (PAH). Ambrisentan has been approved on 20 April 2009 in Korea as an orphan drug for the treatment of PAH to improve exercise ability and delay clinical worsening. Orphan drug designation for Ambrisentan will be revoked and it is to be approved as a new drug in 2015 for the same indication. Therefore post marketing surveillance will be conducted to monitor the safety and effectiveness based on the data collected in Korean subject in a real clinical practice according to PMS regulation. It is an open-label, single arm, multi centre study with a surveillance period planned from 2016 to 2021. About 600 subjects will be recruited for up to 6 years according to PMS regulation. For initial 2 years periodic report every 6 months will be submitted after approving the product as a new drug and later every 1 year for the remaining follow-up years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects having adverse event (AE) and serious adverse event (SAE).

Timeframe: 12 weeks

Secondary outcomes:

Six minutes walk distance (6 MWD) as an evaluation of effectiveness of Ambrisentan

Timeframe: Enrollment and Week 12

World Health Organization (WHO) functional class as an evaluation of effectiveness of Ambrisentan

Timeframe: Enrollment and Week 12

Borg Dyspnea Index (BDI) measurement as an evaluation of effectiveness of Ambrisentan

Timeframe: Enrollment and Week 12

Interventions:
  • Drug: VOLIBRIS
    • Enrollment:
    600
    Primary completion date:
    2021-01-11
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Kina Jeon, Sang-Bae Yoo, Yoonhee Lee, Eun-Bin Lee, Hyung-Kwan Kim, Hyuk-Jae Chang, Sung-A Chang. Safety and effectiveness of ambrisentan in real clinical practice in pulmonary arterial hypertension: Results from the Korean post-marketing surveillance. Pharmacoepidemiology and drug safety. 2023-Jul-27; DOI:10.1002/pds.5671 PMID: 37501534
    Medical condition
    Hypertension, Pulmonary
    Product
    ambrisentan
    Collaborators
    Not applicable
    Study date(s)
    September 2016 to November 2021
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Not applicable
    • Korean subjects with WHO functional class II or III pulmonary arterial hypertension (PAH) (WHO Group 1)
    • Subjects at an age of 18 or older who will administer (new users) or are administering (repeated users) VOLIBRIS according to locally approved prescribing information
    • Female who is pregnant or has possibility of being pregnant
    • Subject who is breast-feeding
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Korean subjects with WHO functional class II or III pulmonary arterial hypertension (PAH) (WHO Group 1)
    • Subjects at an age of 18 or older who will administer (new users) or are administering (repeated users) VOLIBRIS according to locally approved prescribing information
    Exclusion criteria:
    • Female who is pregnant or has possibility of being pregnant
    • Subject who is breast-feeding
    • Subject with severe hepatic impairment (with and without cirrhosis)
    • Subject with aminotransferase (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) > 3 x Upper Limit of Normal (ULN)
    • Subject who experienced hypersensitivity to the ingredient.
    • Subject with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
    • Subject with idiopathic pulmonary fibrosis (IPF) (with and without secondary pulmonary arterial hypertension)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
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    Statistical analysis plan
    Available language(s): English
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    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
    2021-01-11
    Actual study completion date
    2021-01-11

    Plain language summaries

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

    Additional information about the trial

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    Additional information
    Interim CTR Summary
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    Access to clinical trial data by researchers
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