Safety and therapeutic effects of anti-fibrotic Traditional Chinese Medicine Fuzheng Huayu on persistent advanced stage fibrosis following 2 years entecavir treatment: Study protocol for a single arm clinical objective performance criteria trial.
Contemp Clin Trials Commun
; 19: 100601, 2020 Sep.
Article
en En
| MEDLINE
| ID: mdl-32642592
AEs, adverse events; CPs, Clinical Patterns; CRC, Clinical Research Coodinator; CRO, Central Clinical Research Organization; Cirrhosis; EDC, Electronic Data Collection; Entecavir; FZHY, FuZheng HuaYu; Fuzheng huayu tablet; GMP, Good Manufacturing Practice; HBV, Hepatitis B virus; HSCs, Hepatic Stellate Cells; Hepatitis B virus; Liver fibrosis; NAs, Nucleos(t)ide analogues; NMPA, National Medical Products Administration; OPC, objective performance criteria; PDGF-BB, Platelet Derived Growth Factor-BB; PHBC-PRO, patient reported outcomes of post-hepatitic B cirrhosis; PI, principal investigator; Regression; TCM, Traditional Chinese medicine; TGF-ß1, Transforming Growth Factor-beta 1; US FDA, United States Food and Drug Administration; WHO, World Health Organization
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
2_ODS3
Problema de salud:
2_cobertura_universal
Tipo de estudio:
Guideline
Aspecto:
Patient_preference
Idioma:
En
Revista:
Contemp Clin Trials Commun
Año:
2020
Tipo del documento:
Article
País de afiliación:
China
