WEUSKOP5410: Observational Study in ENABLE Clinical Trials
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current
mainstay of treatment is combination therapy with pegylated interferon and ribavarin.
Thrombocytopenia as a treatment related adverse event or a complication of chronic liver
disease often necessitates dose reduction and discontinuation in these patients.
Revolade®/Promacta® (eltrombopag) is an oral second generation thrombopoietic growth factor
in development for the treatment thrombocytopenia associated with various conditions,
including secondary thrombocytopenia related to CLD and hepatitis C. In 2009 a phase III
trial for CLD patients undergoing an elective invasive procedure (ELEVATE) was terminated
early due to an imbalance of thromboembolic events (TEE) between the placebo and the
eltrombopag arm. Currently, two global interventional Phase III trials (ENABLE 1 and ENABLE
2) are being conducted in approximately 1500 patients to evaluate the efficacy of eltrombopag
in enabling HCV patients to achieve sustained viral response. Due to the similarities between
the patient groups in ELEVATE and ENABLE, there is a concern that invasive procedures may
influence the risk of TEE in the ENABLE population. This observational, non-interventional,
retrospective, multicentre, nested case-control study will collect data from chart
abstraction and medical record review to augment data from the ENABLE case report forms
particularly with regards to invasive procedures. The study population includes cases and
controls drawn from the ~1500 participants of the ENABLE trials. All eligible cases of TEE
will be included in the study as cases. All other patients who participated in the ENABLE
trials and did not experience a TEE, will be eligible to be selected as controls. Case report
forms will be developed to enable standardized data capture. The Sponsor has contracted with
the Clinical Research Organization, Outcome Sciences Inc to manage the study. ENABLE
investigators will work with Outcome staff to obtain relevant information from the treating
physician (e.g. surgeon) and the facility where the invasive procedure was performed
(pre-operative tests, peri-operative course, diagnostic testing for TEE). Single point
abstraction will be performed to obtain data from the medical record and from any additional
data resources obtained by the investigator (e.g., operative note, anesthesia record).
Analyses will be conducted using logistic regression models to estimate the risks. The
primary objective of the study is to evaluate if there is an increased risk for TEE among
patients who had an invasive procedure while exposed to eltrombopag (during the ENABLE
trials).