Ethics approval and consent to participate
The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and the requirements of the China Food and Drug Administration. An independent ethics committee approved the study at each study site: Peking Union Medical College Hospital Ethics Committee; West China Hospital, Sichuan University Ethics Committee; Huashan Hospital, Fudan University Ethics Committee; Huazhong University of Science and Technology Clinical Trial Ethics Committee; The First Affiliated Hospital, Sun Yat-sen University Ethics Committee; The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital) Ethics Committee; The Second Hospital of Hebei Medical University Ethics Committee; The Affiliate Hospital of Guizhou Medical University Ethics Committee; Fujian Provincial Hospital Ethics Committee; Tianjin Medical University General Hospital Ethics Committee. All study documentation was approved by institutional review boards. Key protocol amendments occurring during the study are summarized in Additional file 1.
Patients provided written (dated and signed) informed consent to participate in the core study and the PK subgroup. Patients could withdraw at any time during the study either at their own request or if, in the opinion of the investigator, there were safety concerns.
This article does not contain any studies with animals performed by any of the authors.
Consent for publication
Not applicable
Availability of data and materials
Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in this article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available. Proposals should be submitted to [email protected] and will be assessed by a scientific review board. Data are available beginning 6 months and ending 5 years after publication; after this time, only raw data may be available.
Competing of interest
LDG is an employee of Ipsen Innovation. YW is an employee of Ipsen Pharma. NW was an employee of Ipsen Pharma at the time of the study and manuscript development. ZN, TL, LD, PH, ZG, LZ and FG have no conflict of interest.
Funding
This study, including design, data collection, analyses, interpretation, and writing of the manuscript, was sponsored by Ipsen.
Author contributions
All authors additionally revised the work critically for important intellectual content, approved the final version to be published, and agree to be accountable for all aspects of the work.
ZA: conducted trial in the West China Hospital site
TL: conducted trial in the Tongji Hospital site
LD: conducted trial in the PUMCH site
PH: conducted PK subgroup study in the PUMCH site
ZG: conducted PK subgroup study in the West China Hospital
LZ: conducted trial in the second hospital of Hebei Medical University site
LDG: designed the PK model and analyzed PK data
NW: designed statistical analysis plan and analyzed study results
YW: reviewed study data and results
FG: designed and guided trial in China; reviewed and summarized data
Acknowledgements
The authors thank all patients involved in the study, as well as their care team, investigators and research staff in participating institutions.
The authors would also like to thank all the LANTERN study investigators: West China Hospital, Sichuan University, Sichuan: Z.M. An, Z.P. Gou, J.W. Li, H.W. Tan, Q. Peng, L.B. Liang, Y.J. Li, P. Feng, L. Zheng. Tongji Hospital, Tongji Medical College of HUST, Wuhan: T. Lei, H.Q. Zhang, C.X. Li, C. Gan, Y. Xu. Peking Union Medical College Hospital, PUMCH, Beijing: F. Gu, P. Hu, L. Duan, X. Chen, J. Li, W.G. Zhu. The second hospital of Hebei Medical University, Shijiazhuang: L.H. Zhang, S.Y. Zhang, F. Zhang, J. Li. The first affiliated hospital, Sun Yat-sen University, Guangzhou: Y.B. Li, H.J. Wang, Z.G. Mao, Z.H. Liao, Z.Y. Chen. Huashan Hospital, Fudan University, Shanghai: Y. Mao, S.Q. Li, Y. Zhao, M. Shen. The first affiliated hospital of Nanjing Medical University (Jiangsu Province Hospital), Nanjing: T. Yang, X.Q. Zheng, Z.X. Wang, R. Gu. The affiliated hospital of Guizhou Medical University (previously the affiliated hospital of Guiyang Medical College), Guiyang: L.X. Shi, M. Zhang, B.H. Xiao. Fujian Provincial Hospital, Fuzhou: J.M. Hou, J.P. Wen, Y. Lin, X.H. Lan, W. Lin, J.X. Liang. Tianjin Medical University General Hospital: M. Zhu, H.W. Jia, J. Cui, F.A. Li.
Authors’ information
West China Hospital, Sichuan University, Sichuan, China
Zhenmei An, Zhongping Gou
Tongji Hospital, Tongji Medical college of HUST, Wuhan, China
Ting Lei
Peking Union Medical College Hospital, PUMCH, Beijing, China
Lian Duan, Pei Hu, Feng Gu
The second hospital of Hebei Medical University, Shijiazhuang, China
Lihui Zhang
Ipsen Innovation, Les Ulis, France
Lucie Durand-Gasselin
Ipsen Pharma, Beijing, China
Nan Wang, Yan Wang
Medical writing support
The authors thank Chris Deakin, PhD, and Louise Prince, PhD, of Watermeadow Medical for providing medical writing support, which was sponsored by Ipsen in accordance with Good Publication Practice guidelines.