Phase 3 Completed N=27 Treatment

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

Source: ClinicalTrials.gov NCT00996216 ↗

Enrolled (actual)

Serious AEs

9.6%

Results posted

Dec 2013

Primary outcomePrimary: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 — 0; 9 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1	0; 9	—
PRIMARY Number of Participants With Any AE and Any SAE in Part 2	5; 25	—
PRIMARY 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	2; 1; 0; 1; 0; 1	—
PRIMARY 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	4; 3; 0; 1; 0; 9	—
PRIMARY Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1	2; 2; 0; 0; 0; 3	—
PRIMARY Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2	12; 1; 5; 5; 1; 15	—
PRIMARY Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2	10; 15; 2	—
PRIMARY Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2	15; 6; 3; 1; 2	—
PRIMARY Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2	4; 21; 2	—
SECONDARY Platelet Counts at the Indicated Time Points	53.1; 55.9; 73.3; 83.2; 73.4; 75.6	—
SECONDARY Number of Particpants Who Initiated Antiviral Therapy	25; 2	—
SECONDARY 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)	4; 13; 3; 9; 15; 0	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00996216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.