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高雄醫學大學附設中和紀念醫院-臨床試驗中心KMUH Clinical Trial Center

  • Total Beds1,704
  • Total Doctors806
  • AddressNo.100, Tzyou 1st Rd., Sanmin Dist.,Sanmin,Kaohsiung City 807
  • Emailctc@ms.kmuh.org.tw

1. Full accredited from the AAHRPP (2018.12) and JCI (2019.01).

2. Conduct about 400 clinical trials every year, and over 70% were multicenter research trial.

3. First site that had been approved by MOHW for face transplant clinical trial in Taiwan.

Site Introduction

Besides taking good care of our patients, Kaohsiung medical university hospital has devoted every effort in facilitating the competency of clinical trial keeping that clinical trial is the cornerstone in promoting the standard of care and keeping with global medical proficiency. We have signed memorandum of understanding with many international pharmaceutical companies, Metal Industries Research & Development Center (MIRDC), Lu-Ju scientific park. Kaohsiung medical university hospital has become one of the major clinical trial centers in Taiwan. To consolidate the platform of clinical trial, KMUH enrolls center for evidence-base medicine and statistics, and department of laboratory medicine as team member to provide the support from basic science and statistical analysis.

Clinicl Trial Expertise

Hepatitis, Colorectal Cancer, Breast Cancer, Lung Cancer

International Accreditation

Full accredited from the AAHRPP in Dec, 2018
2nd accredited by Joint Commission International (JCI) in Feb, 2019

GCP Inspection/audit

In 2010/5 and 2016/7, the clinical trial team of Prof. Wan-Long Chuang was approved by USFDA

2015/5, Protocol # HGS1008-C1067, Alfa-2b(alb-IFN)
2016/7, Protocol # GS-US-320-0108, TAF, GS-7340/Viread®

What types of clinical trial do you conduct?

Publications

CTC

1

Abou-Alfa, G. K., Qin, S., Ryoo, B. Y., Lu, S. N., Yen, C. J., Feng, Y. H., . . . Chen, L. T. (2018). Phase III randomized study of second line ADI-PEG 20 plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma. Ann Oncol, 29(6), 1402-1408. doi: 10.1093/annonc/mdy101 (I.F. 13.926)

2

Agarwal, Kosh, Brunetto, Maurizia, Seto, Wai Kay, Lim, Young-Suk, Fung, Scott, Marcellin, Patrick, . . . Bae, Ho. (2018). 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. Journal of hepatology, 68(4), 672-681. (I.F. 14.911)

3

Chang, C. J., Chen, C. H., Chen, B. M., Su, Y. C., Chen, Y. T., Hershfield, M. S., . . . Wu, J. Y. (2017). A genome-wide association study identifies a novel susceptibility locus for the immunogenicity of polyethylene glycol. Nat Commun, 8(1), 522. doi: 10.1038/s41467-017-00622-4 (I.F. 12.124)

4

Dai, C. Y., Chuang, W. L., & Yu, M. L. (2014). A 24-week pegylated interferon alpha-2b versus a 12-week pegylated interferon alpha-2b alone or with ribavirin for patients with acute hepatitis C. Hepatology, 60(6), 2128-2129. doi: 10.1002/hep.27096 (I.F.11.190)

5

Kuo, S. H., Chen, L. T., Lin, C. W., Yeh, K. H., Shun, C. T., Tzeng, Y. S., . . . Cheng, A. L. (2017). Expressions of the CagA protein and CagA-signaling molecules predict Helicobacter pylori dependence of early-stage gastric DLBCL. Blood, 129(2), 188-198. doi: 10.1182/blood-2016-04-713719 (I.F. 13.164)

6

Liu, C. J., Chuang, W. L., Sheen, I. S., Wang, H. Y., Chen, C. Y., Tseng, K. C., . . . Chen, P. J. (2018). Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV. Gastroenterology, 154(4), 989-997. doi: 10.1053/j.gastro.2017.11.011 (I.F. 20.773)

7

Su, Y. C., Burnouf, P. A., Chuang, K. H., Chen, B. M., Cheng, T. L., & Roffler, S. R. (2017). Conditional internalization of PEGylated nanomedicines by PEG engagers for triple negative breast cancer therapy. Nat Commun, 8, 15507. doi: 10.1038/ncomms15507 (I.F. 12.124)

8

Tsai, P. C., Huang, C. F., & Yu, M. L. (2017). Unexpected early tumor recurrence in patients with hepatitis C virus-related hepatocellular carcinoma undergoing interferon-free therapy: Issue of the interval between HCC treatment and antiviral therapy. Journal of Hepatology, 66(2), 464-464. doi: DOI 10.1016/j.jhep.2016.10.035 (I.F. 12.486)

9

Wang, C. Y., Wong, W. W., Tsai, H. C., Chen, Y. H., Kuo, B. S., Lynn, S., . . . Liao, M. J. (2019). Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption. N Engl J Med, 380(16), 1535-1545. doi: 10.1056/NEJMoa1802264 (I.F. 70.670)

10

Yen, Yung-Feng, Chuang, Pei-Hung, Jen, I-An, Chen, Marcelo, Lan, Yu-Ching, Liu, Yen-Ling, . . . Chen, Yi-Ming Arthur. (2017). Incidence of autoimmune diseases in a nationwide HIV/AIDS patient cohort in Taiwan, 2000–2012. Annals of the rheumatic diseases, 76(4), 661-665. (I.F. 12.811)