Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00996216
• Date of registration: 01/10/2009
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Clinical Trial for Non-responders Who Previously Participated in Eltrombopag Studies TPL 103922 or TPL 108390 ENABLE-ALL
• 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)
• Date of first enrolment: September 2009
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00996216
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Canada, Czech Republic, France, Germany, Greece, Italy, Pakistan, Puerto Rico, Slovakia, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: Antiviral therapy

Drug: Eltrombopag

Primary Outcome(s)

Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 [Time Frame: 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 Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 [Time Frame: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)]

Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 [Time Frame: 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 Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 [Time Frame: 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 Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 [Time Frame: 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 the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 [Time Frame: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)]

Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 [Time Frame: 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 Decrease in Visual Acuity During Parts 1 and 2 [Time Frame: 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 Any AE and Any SAE in Part 2 [Time Frame: 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)]

Secondary Outcome(s)

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) [Time Frame: 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)]

Platelet Counts at the Indicated Time Points [Time Frame: 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 [Time Frame: From the start of the investigational product up to 9 weeks (median of 21 days)]

Secondary ID(s)

108392

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/12/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00996216