Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults: A phase I/II, prospective, randomized, open-label trial

Vaccine ◽  
2017 ◽  
Vol 35 (33) ◽  
pp. 4099-4104 ◽  
Author(s):  
Un-In Wu ◽  
Szu-Min Hsieh ◽  
Wen-Sen Lee ◽  
Ning-Chi Wang ◽  
Hsiang-Chi Kung ◽  
...  
PLoS ONE ◽  
2015 ◽  
Vol 10 (11) ◽  
pp. e0141687 ◽  
Author(s):  
Sharon Sheehan ◽  
Stephanie A. Harris ◽  
Iman Satti ◽  
David A. Hokey ◽  
Veerabadran Dheenadhayalan ◽  
...  

2019 ◽  
Author(s):  
Kazuhiro Yamamoto ◽  
Takeshi Ioroi ◽  
Kenichi Harada ◽  
Satoshi Nishiyama ◽  
Chikako Nishigori ◽  
...  

BACKGROUND Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for its prevention has not been established. Specific ascorbic acid derivatives can reverse multiple-TKI-induced keratinocyte growth and pathological changes in vitro. OBJECTIVE This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel, hydrosoluble, and moisturizing ascorbic acid derivative, in patients with renal cell carcinoma (RCC) receiving sunitinib therapy. This study was also designed to evaluate Amitose DGA’s preventive efficacy for sunitinib-induced HFSR. METHODS This is a Phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week-on and 1-week-off schedule. The participants will apply Amitose DGA-containing cream over both palmar and plantar surfaces within two treatment cycles (ie, 6 weeks) of sunitinib in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib. RESULTS Recruitment to the study began in August 2017 and is ongoing in Japan. To date, 21 subjects have been recruited. Study completion is expected in 2021. CONCLUSIONS This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000027209; https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/14636


2009 ◽  
Vol 54 (1) ◽  
pp. 77-85 ◽  
Author(s):  
Johan Scharpé ◽  
Willy E. Peetermans ◽  
Johan Vanwalleghem ◽  
Bart Maes ◽  
Bert Bammens ◽  
...  

2016 ◽  
Vol 27 ◽  
pp. vi377 ◽  
Author(s):  
S. Domchek ◽  
Y.-J. Bang ◽  
G. Coukos ◽  
K. Kobayashi ◽  
N. Baker ◽  
...  

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