Date: 2011-11-07
Type of information: Initiation of preclinical development
phase: 3
Announcement: results
Company: GSK (UK)
Product: eltrombopag
Action
mechanism: thrombopoietin agonist. Eltrombopag works by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells.
Disease: hepatitis C virus related thrombocytopenia
Therapeutic area: Infectious diseases
Country:
Trial
details: The ENABLE 1 trial enrolled 716 adults with HCV and platelet levels less than 75,000/µL into an open label eltrombopag treatment period. Those who achieved platelet levels greater than or equal to 90,000/µL were randomly assigned on a 2 to 1 basis to eltrombopag or placebo plus peginterferon alfa-2a and ribavirin.
The ENABLE 2 trial enrolled 805 adults with HCV and platelet levels less than 75,000/µL into an open label eltrombopag treatment period and those who achieved platelet levels greater than or equal to 100,000/µL were randomly assigned on a 2 to 1 basis to eltrombopag or placebo plus peginterferon alfa-2b and ribavirin. Analyses are ongoing and full study results will be submitted for presentation at a future medical meeting.
Latest
news: GSK has presented phase III results for eltrombopag in hepatitis C virus related thrombocytopenia. Findings from the ENABLE clinical trials, which evaluated the ability of eltrombopag to raise and maintain platelet levels in patients with chronic hepatitis C virus (HCV) infection and low platelet levels that would preclude initiation of interferon-based antiviral therapy, were presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco.
In ENABLE 1, patients who received eltrombopag along with Pegasys® (peginterferon alfa-2a) and ribavirin antiviral therapy achieved a statistically significant improvement in the primary endpoint of sustained virologic response (SVR), a clinically validated endpoint that means there is no detectable hepatitis C virus in a patient’s blood. 23% of patients in the eltrombopag group achieved SVR compared to 14% of patients receiving placebo (p=0.0064).
Serious adverse events were reported in 20% of eltrombopag and 15% of placebo patients. During the entire study period death occurred in 2% of patients in the eltrombopag and 3% in the placebo group. Thromboembolic events were reported in 2% of eltrombopag patients and 2% of placebo patients. Elevations in liver enzymes were similar in both groups. Events consistent with worsening of liver function were reported in 13% of eltrombopag patients and 8% of placebo patients.
Initial data from ENABLE 2, a randomised Phase III trial of eltrombopag plus PEG-Intron® (peginterferon alfa-2b) and ribavirin were also presented. The ENABLE 2 trial met its primary endpoint of improved SVR, with 19% of eltrombopag patients and 13% of placebo patients achieving SVR (p=0.0202). Serious adverse events were reported in 20% of eltrombopag and 15% of placebo patients. Death occurred in 4% of patients in the eltrombopag and 2% of placebo group. Thromboembolic events were reported in 4% of eltrombopag patients and less than 1% of placebo patients. Elevations in liver enzymes were similar in both groups. Events consistent with worsening of liver function were reported in 15% of eltrombopag patients and 8% placebo patients.
