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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00996216




Registration number
NCT00996216
Ethics application status
Date submitted
1/10/2009
Date registered
16/10/2009
Date last updated
6/12/2013

Titles & IDs
Public title
Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390
Scientific 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)
Secondary ID [1] 0 0
108392
Universal Trial Number (UTN)
Trial acronym
ENABLE-ALL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eltrombopag
Treatment: Drugs - Antiviral therapy

Experimental: Open-label eltrombopag - Open-label eltrombopag with dose titrations to support adequate platelet counts.


Treatment: Drugs: Eltrombopag
Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.

Treatment: Drugs: Antiviral therapy
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
Timepoint [1] 0 0
From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Primary outcome [2] 0 0
Number of Participants With Any AE and Any SAE in Part 2
Timepoint [2] 0 0
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)
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
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)
Primary outcome [5] 0 0
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1
Timepoint [5] 0 0
From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Primary outcome [6] 0 0
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2
Timepoint [6] 0 0
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)
Primary outcome [7] 0 0
Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2
Timepoint [7] 0 0
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)
Primary outcome [8] 0 0
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2
Timepoint [8] 0 0
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)
Primary outcome [9] 0 0
Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2
Timepoint [9] 0 0
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 outcome [1] 0 0
Platelet Counts at the Indicated Time Points
Timepoint [1] 0 0
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 outcome [2] 0 0
Number of Particpants Who Initiated Antiviral Therapy
Timepoint [2] 0 0
From the start of the investigational product up to 9 weeks (median of 21 days)
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
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)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
France
State/province [9] 0 0
Marseille Cedex 08
Country [10] 0 0
France
State/province [10] 0 0
Nice cedex 3
Country [11] 0 0
France
State/province [11] 0 0
Pessac Cedex
Country [12] 0 0
Germany
State/province [12] 0 0
Baden-Wuerttemberg
Country [13] 0 0
Germany
State/province [13] 0 0
Bayern
Country [14] 0 0
Germany
State/province [14] 0 0
Nordrhein-Westfalen
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
Italy
State/province [17] 0 0
Emilia-Romagna
Country [18] 0 0
Italy
State/province [18] 0 0
Liguria
Country [19] 0 0
Italy
State/province [19] 0 0
Lombardia
Country [20] 0 0
Pakistan
State/province [20] 0 0
Lahore
Country [21] 0 0
Spain
State/province [21] 0 0
La Coruña
Country [22] 0 0
Spain
State/province [22] 0 0
Madrid
Country [23] 0 0
Spain
State/province [23] 0 0
Pontevedra
Country [24] 0 0
Spain
State/province [24] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00996216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00996216