Phase 2a Study of AL-335, Odalasvir, with/without Simeprevir for Hep C
Research type
Research Study
Full title
A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, with or without Simeprevir, in Treatment-Naïve Subjects with Genotype 1, 2 or 3 Chronic Hepatitis C infection with or without compensated Child Pugh A Cirrhosis
IRAS ID
217915
Contact name
Kosh Agarwal
Contact email
Sponsor organisation
Alios BioPharma, Inc.
Eudract number
2016-002845-46
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 3 days
Research summary
Approximately 170 million people worldwide are infected with hepatitis C virus (HCV) with more than 365,000 deaths per year resulting from e.g. cirrhosis (condition in which the liver does not function properly due to long term damage and scarring) and liver cancer. The risk of hepatic decompensation in subjects with cirrhosis is approximately 5% per year and the 5year survival rate after decompensation is around 50%. Chronic hepatitis C (CHC) is the leading cause for liver transplantation in EU and USA.
The purpose of this clinical study is to help determine whether the study drugs AL-335, in combination with Odaslavir with or without Simeprevir are safe, tolerable and effective at reducing the amount of HCV in the blood to help treat and or prolong survival rates.
This global study will recruit up to 320 participants (between 10-20 participants per group with a possible 16 groups in total) with previously untreated CHC infection, who are between 18 and 70years and meet the inclusion criteria.
The study could take up to 43wks to complete but could be less depending on the treatment group assigned. The study is divided into three parts;
• Screening Period - up to 50 days to check eligibility
• Treatment period - either 4, 6, 8, or 12wks of study drug treatment
• Follow-up period - up to 24wks following study drug treatment to monitor how effective the treatment has been.Before any study procedures are undertaken Informed Consent will be required. At scheduled study visits, participants will need to visit the hospital/research site where several assessments will take place (physical exam, blood & urine tests, electrocardiogram, echocardiogram, ultrasound). Side effects will be monitored throughout the study.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0415
Date of REC Opinion
3 Feb 2017
REC opinion
Further Information Favourable Opinion