Open label ABT493 and ABT530 with and without Ribavirin in HCV
Research type
Research Study
Full title
An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
IRAS ID
172971
Contact name
David Mutimer
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2014-002925-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 9 days
Research summary
The purpose of this study is to evaluate the effects of the study drugs ABT-493 and ABT-530, with or without RBV (ribavirin), in people who have chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection with compensated cirrhosis (in people with genotype 1) or without cirrhosis (all genotypes).
About 80 people with HCV have participated in part 1 of the study, while approximately 240 will participate in part 2.
Part 1 of the study was conducted in the USA. Part 2 will begin once the applicable study data is reviewed from part 1.
Part 1:
Patients who participated in part 1 of the study were assigned to one of the following treatment arms:
Arm A: 200 mg ABT-493 and 120 mg ABT-530 once daily for 12 weeks.
Arm B: 200 mg ABT-493 and 40 mg ABT-530 once daily for 12 weeks.Part 1 of the study has completed enrolment under Protocol Amendment 1 and no additional participants will be enrolled into arms A or B. There is a chance that some or all arms (C, D, E, F, G, H, I, and J) in part 2 will not be opened.
Part 2:
Participants who have HCV genotype 1 without cirrhosis may be enrolled into one of the following arms:
Arm C: 200 mg ABT-493 and 120 mg ABT-530 once daily for 8 weeks.
Arm D: 200 mg ABT-493 and 40 mg ABT-530 once daily for 8 weeks.Participants who have HCV genotype 1 with cirrhosis may be enrolled into one of the following arms:
Arm E: 200 mg ABT-493, 120 mg ABT-530 and 800 mg RBV once daily for 12 weeks.
Arm F: 200 mg ABT-493 and 120 mg ABT-530 once daily for 12 weeks.
Arm G: 200 mg ABT-493, 40 mg ABT-530 and 800 mg RBV once daily for 12 weeks.
Arm H: 200 mg ABT-493 and 40 mg ABT-530 once daily for 12 weeks.Participants who have HCV genotype 4, 5 or 6 without cirrhosis may be enrolled into one of the following arms:
Arm I: 200 mg ABT-493 and 120 mg ABT-530 once daily for 12 weeks.
Arm J: 200 mg ABT-493 and 40 mg ABT-530 once daily for 12 weeks.A number of assessments will be performed during the study including physical examinations, measurements of body weight, blood pressure and pulse rate, blood tests, urine tests, and electrocardiograms. These assessments are performed as part of the evaluation to determine if the study drugs are effective and safe.
The study will be run at approximately 6 centres in the UK and is sponsored by AbbVie.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0077
Date of REC Opinion
10 Apr 2015
REC opinion
Further Information Favourable Opinion