Redefining Test-and-Treat to assure chronic hepatitis C elimination in individuals-at-risk through point-of-care treatment as part of ‘Fast Track City’ initiative in Berlin - REACH C

Charité Universitätsmedizin Berlin0 个研究点目标入组 80 人开始时间: 2026年11月1日最近更新: 2026年8月3日

适应症

试验速览

暂无简介。

•Subjects with the following characteristics:
•Positive test for HCV RNA in PCR
•Capable of written informed consent for study participation.
•The inclusion into the study is possible without current access to health care insurance coverage, as the study population usually has either limited or no access to health insurance coverage and would (following standard-of-care) otherwise not be able to receive treatment for HCV.

•Subjects with the following characteristics:
•Younger than 18 years of age
•Incapable of written informed consent
•In a legal guardianship relationship (according to §1814 BGB)
•With (high-grade) evidence of decompensated cirrhosis as assessed by the health care professional
•Pregnancy
•Currently on medication that is contraindicated for coadministration with GLE/PIB as per German drug label
•The exclusion criteria do not consider a participant’s insurance status. A previously diagnosed and successfully treated hepatitis C virus infection is likewise not an exclusion criterion. Ongoing intravenous drug use and opioid substitution therapy are also not grounds for exclusion.
•Participants who, at screening, show evidence of decompensated liver cirrhosis - such as hepatic encephalopathy, active infection, ascites or hydropic decompensation, markedly reduced urine output indicative of severe renal dysfunction, or recent variceal or non-variceal bleeding - should be referred to a hepatology-specialized healthcare facility for further management.

发起方