open-label trial


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open-label study

A clinical study in which the patients/subjects and investigators know which product each patient/subject is receiving, which is the opposite of a blinded study.

open-label trial

Clinical research A trial in which doctors and participants know which therapy is being administered. See Blinding.
References in periodicals archive ?
Neptune was a randomised, open-label trial of previously untreated patients with stage four non-small cell lung cancer.
We commenced dosing in our Phase 2 trial of 1095 and, assuming early positive data from this open-label trial, see potential to advance 1095 into a pivotal trial in 2020 following agreement from the FDA.
The ongoing Phase 1/2, open-label trial (NCT02551991) was aimed at evaluating the safety, tolerability and dose-limiting toxicities of the study drug, liposomal irinotecan, in combination with 5-FU/LV and OX, known as NAPOX, for the first-line treatment of study participants with metastatic pancreatic cancer.
The Phase 1/2 open-label trial is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with TDT, non-beta zero/beta zero subtypes.
In a nonrandomized, open-label trial of 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received systemic treatment for the advanced disease, the overall response rate was 56% with a complete response rate of 24%; median response duration was not reached.
Rockson, M.D., from Stanford University School of Medicine in California, and colleagues conducted an exploratory open-label trial involving patients with primary or secondary lymphedema.
Trovagene is initiating a Phase lb/II open-label trial to evaluate the safety and anti-leukemic activity of PCM-075 in combination with standard-of-care in patients with AML, at ten research sites across the U.S.
In a multicenter, open-label trial, Japanese researchers tested whether low-dose aspirin prevented adverse cardiovascular events in more than 14,000 patients, aged 60 to 85, who had atherosclerotic risk factors such as hypertension, dyslipidemia (an abnormal lipid profile), or diabetes mellitus.
TURQUOISE II was an international, multicenter, randomized, open-label trial of 380 patients with Child-Pugh class A cirrhosis caused by HCV infection, said Dr.
The poster reported on an open-label trial run by the Royal Free London NHS Foundation Trust at two sites in the UK and Ireland and which included data from 21 patients, five of whom were followed for twelve months.
"This was an open-label trial and, as such, it cannot be regarded as evidence of efficacy; only safety can be assessed to some degree," he wrote.
This is a randomised open-label trial investigating the efficacy of continuous dosing of AXL1717.