A study of RO7020531 in healthy subjects and patients with hepatitis B
Research type
Research Study
Full title
A PHASE I, SPONSOR-OPEN, INVESTIGATOR-BLINDED, SUBJECT-BLINDED, MULTI-CENTER, PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORAL ADMINISTRATION OF RO7020531: (1). SINGLE AND MULTIPLE ASCENDING DOSES IN HEALTHY MALE AND FEMALE SUBJECTS; (2). 6-WEEK TREATMENT OF VIROLOGICALLY SUPPRESSED PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION
IRAS ID
230354
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2016-003723-38
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
The purpose of the study is to test if the study drug is safe, tolerated and effective at treating patients with hepatitis B virus infection.
About 30 people will participate in part 2 of the study. Eligible patients will be randomly assigned to receive treatment with either study drug (group A) or placebo (group B). A placebo is a substance that looks like the active study drug but contains no active medication (like a ‘sugar pill’). Patients will be dosed either the study drug or placebo for 6 weeks, and followed up for another 6 weeks.
All patients will continue to be treated with their hepatitis B treatment (tenofovir, entecavir, adefovir, or telbivudine, either as single agents or in combination), once per day during this study (both during the dosing period and follow-up period).
A number of assessments and procedures will be performed during the study including physical examinations, electrocardiograms, blood and urine sample assessments. These assessments are performed as part of the evaluation to determine if the study drug is effective, well tolerated and safe.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1469
Date of REC Opinion
6 Oct 2017
REC opinion
Favourable Opinion