Study of Females Exposed to Eleclazine
Research type
Research Study
Full title
Study of Females Exposed to Eleclazine.
IRAS ID
313891
Contact name
Nigel Mark Wheeldon
Contact email
Sponsor organisation
Gilead Sciences, Inc
Duration of Study in the UK
0 years, 0 months, 30 days
Research summary
The purpose of this safety follow-up study is to follow up with women who were exposed to eleclazine in prior clinical studies, in order to check whether other women developed uterine cancer after being treated with eleclazine.
The safety follow-up study consists of at least one visit. A visit with the study doctor and possible referral for Gynecological evaluation.Summary of Results
CONCLUSIONS:
The purpose of this study was to follow up with females exposed to eleclazine in prior clinical trials to assess signs or symptoms potentially consistent with uterine cancer. A total of 177 female participants were exposed to eleclazine in a prior eleclazine clinical trial and 77 of those participants were enrolled in this study, including 8 participants enrolled using an ICF waiver.Of the 69 enrolled participants excluding participants enrolled with a waiver, 6 participants (8.7%) had signs and symptoms potentially consistent with uterine cancer and none of the participants had uterine cancer. Eight (8) deaths occurred after the prior eleclazine clinical trial and prior to this study; these were the participants enrolled with ICF waiver, none of whom had a reported cause of death due to cancer of any type (one participant had an unknown cause of death). An additional death of unknown cause was reported in the Gilead’s Global Safety Database. Per the Safety Database, none of these 9 deaths were related to eleclazine. This follow-up study did not provide any evidence to support a potential association between eleclazine and uterine cancer.
REC name
West of Scotland REC 1
REC reference
22/WS/0096
Date of REC Opinion
7 Sep 2022
REC opinion
Further Information Favourable Opinion