ocalized on site testing and treatment of hepatitis C in homeless persons in London: a pilot non-randomised phase 4 interventional clinical trial of grazoprevir and elbasvir ± ribavirin in participants with genotype 1a, 1b or 4 to measure efficacy and adherence to treatment in a homeless population - ATTIC - Access To Treat in the Community

Kings College Hospital NHS Foundation Trust0 个研究点目标入组 150 人开始时间: 2018年11月5日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•1. Participants 18 years or older
•2. Infected with genotype 1a, 1b or 4 HCV identified on screening
•3. Able and willing to provide written informed consent.
•4. Both interferon treatment naive and experienced participants will
•be included.
•5. Participants without cirrhosis will be eligible if HCV RNA positive,
•documented chronic hepatitis C and a FibroScan of = 12.5.
•6. Participants with cirrhosis (Fibroscan > 12.5 or APRI > 2) will be
•eligible if the serum albumin is > 3.5 g/dl, platelets > 100,000 and
•INR < 1.5 and there is no prior history of hepatic decompensation.
•7. Participants with well controlled HIV co-infection will be included,
•but should be stabilized on antiretrovirals for which no
•clinically significant interaction is expected.
•8. Participants who are HBsAg positive will be included but will require antiviral
•prophylaxis for hepatitis B. Anti-HBc positive participants will be
•included; prophylaxis will not be given but these clients will require
•close monitoring of their ALT elevations
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•1. Persons with prior HCV DAA treatment will be excluded.
•2. Clinically-significant medical or psychiatric illness (other than chronic HCV) in the past,
•present, or being evaluated, that may interfere with participant treatment, safety,
•assessment or compliance with the protocol
•3. Participants with active TB infection will be excluded.
•4. Refusal to practice effective contraception.

发起方

Kings College Hospital NHS Foundation Trust