When is an open-label design considered acceptable by regulatory authorities?

A MULTICENTER, RANDOMIZED OPEN-LABEL TRIAL COMPARING 1-DAY CESSATION OF DIRECT ORAL ANTICOAGULANTS BEFORE AND AFTER COLORECTAL POLYPECTOMY -MADOWAZU TRIAL-. Treating Foot Infections in Diabetic Patients: A Randomized, Multicenter, Open-Label Trial of Linezolid versus Ampicillin-Sulbactam/Amoxicillin-Clavulanate. The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure ... Knowledge on rare diseases and orphan drugs · Search for a clinical trial · A Phase 2 Randomized, Open-Label Trial of PA-824-Containing Regimens Versus Standard ... Conclusions: These data suggest that ligands for the gamma subtype of PPARs may represent a novel therapy for ulcerative colitis. A double blind, placebo- ... Further analysis of scalp biopsies is pending. Microneedling may have a mild effect on hair regrowth in AGA but did not improve SALT score over six months in AA ... Abstract. Purpose: Brentuximab vedotin (BV) is hypothesized to selectively deplete T regulatory cells that express CD30 and resensitize tumors to anti–PD-1 ... Jan 8, 2020 ... The purpose of this research study is to analyze the treatment potential of tofacitinib in patients with sarcoidosis that involves the skin. Official Title. A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered ... Open-label trial of Sibeprenlimab for treatment of IgAN. Research type. Research Study. Full title. A Phase 2/3, Multicenter, Open-label Trial to Evaluate the ...