Last updated: 11/07/2018 02:12:57
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Clinical trial for non-responders who previously participated in eltrombopag studies TPL 103922 or TPL 108390ENABLE-ALL

GSK study ID
108392
See study documents
Clinicaltrials.gov ID
NCT00996216
See results summary
EudraCT ID
2008-000660-17
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: An open-label, multi-centre rollover study to assess the safety and efficacy of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin)
Trial description: The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with any adverse event (AE) and any serious adverse event (SAE) in Part 1

Timeframe: From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Number of participants with any AE and any SAE in Part 2

Timeframe: From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)

Number of participants with the indicated worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) grade increases from Screening for the indicated clinical chemistry parameters during Part 1

Timeframe: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Number of participants with the indicated worst-case DAIDS grade increases from the Antiviral Baseline Visit for the indicated clinical chemistry parameter during Part 2

Timeframe: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

Number of participants with the indicated worst-case DAIDS grade increases from Screening for the indicated hematology parameters during Part 1

Timeframe: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)

Number of participants with the indicated worst-case DAIDS grade increases from the Antiviral Baseline Visit for the indicated hematology parameters during Part 2

Timeframe: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)

Number of participants with a decrease in visual acuity during Parts 1 and 2

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Number of participants with the indicated change in logMAR scale values during Parts 1 and 2

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Number of participants with a logMAR change >=0.15 during Parts 1 and 2

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Secondary outcomes:

Platelet counts at the indicated time points

Timeframe: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Number of particpants who initiated antiviral therapy

Timeframe: From the start of the investigational product up to 9 weeks (median of 21 days)

Number of participants achieving antiviral treatment milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)

Timeframe: From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)

Interventions:
  • Drug: Eltrombopag
  • Drug: Antiviral therapy
    • Enrollment:
    27
    Primary completion date:
    2013-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Berg T, Riordan S, Karamanolis D, Garcia-Samaniego J, Porayko M, Campbell F, Geib J, Iyengar M, Theodore D.ENABLE-ALL: Safety and efficacy of eltrombopag in thrombocytopenic hepatitis C virus-infected patients with cirrhosis who withdrew from the ENABLE-1&2 studies.Hepatol Int.2014;8(supplement 1):S172-S173doi: DOI 10.1007/s12072-014-9519-7
    Medical condition
    Hepatitis C
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to February 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390
    • Male or female ≥18 years old
    • Decompensated liver disease
    • Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390
    • Male or female ≥18 years old
    • Evidence of chronic HCV infection
    • While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia
    • Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin
    • Platelet count <75,000
    • Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment
    • Ability to understand and comply with the protocol requirements and instructions
    • Ability to provide written informed consent
    Exclusion criteria:
    • Decompensated liver disease
    • Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients
    • History of clinically significant bleeding from oesophageal or gastric varices
    • History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer
    • Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
    • Evidence of hepatocellular carcinoma
    • HIV or Hepatitis B infection
    • Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy
    • Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival.
    • Pregnant or nursing women
    • Men with a female partner who is pregnant
    • History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme.
    • Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit
    • History or platelet clumping that prevents reliable measurement of platelet counts
    • Evidence of portal vein thrombosis within three months of baseline visit

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lahore, Pakistan, 54600
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ulm, Baden-Wuerttemberg, Germany, 89081
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bologna, Emilia-Romagna, Italy, 40138
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Genova, Liguria, Italy, 16132
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96817
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 28 Results

    Study documents

    Clinical study report
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2013-28-02
    Actual study completion date
    2013-28-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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