ATTIC - Access To Treat In the Community

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 20.0Level: LLTClassification code 10008914Term: Chronic hepatitis C without mention of hepatic comaSystem Organ Class: 100000004862; hepatitis C viral infection

• Registration Number: EUCTR2018-002251-14-GB
• Lead Sponsor: Kings College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-05
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified