A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01464827
• Date of registration: 28/09/2011
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: A Study of ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 HCV Infected Subjects
• Scientific title: A Randomized, Open Label, Multi-center Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
• Date of first enrolment: October 2011
• Target sample size: 560
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01464827
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom, United States

Contacts

• Name: Daniel Cohen, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria

- Males and females 18-70 years old, inclusive

- Females must be post-menopausal for more than 2 years or surgically sterile or
practicing specific forms of birth control

- Chronic Hepatitis C Virus (HCV), genotype 1 infection

- Treatment naive OR prior null-responders to previous treatment with pegylated
interferon (pegIFN) and Ribavirin (RBV)

- No evidence of liver cirrhosis

Exclusion Criteria

- Positive screen for drugs and alcohol

- Significant sensitivity to any drug

- Use of contraindicated or prohibited medications within 1 month of dosing

- Abnormal laboratory tests



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis C

Hepatitis C (HCV)

Hepatitis C Genotype 1

Intervention(s)

Drug: ABT-267

Drug: ABT-333

Drug: ABT-450/r

Drug: Ribavirin (RBV)

Primary Outcome(s)

Percentage of subjects achieving 24-week sustained virologic response (SVR24) following treatment with different durations of 3 DAAs (direct acting anti-virals) and RBV (ribavirin) in HCV (HepatitisC) genotype 1-infected treatment-naïve adults [Time Frame: Post Treatment Week 24]

Safety of all treatment regimens [Time Frame: Baseline to End of Active Treatment (up to 24 weeks)]

Secondary Outcome(s)

Any emerged or enriched mutations Post-Baseline by mixed population and/or clonal sequencing [Time Frame: Day 1 to Post-Treatment Week 48 or Premature Discontinuation]

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment of different durations with 3 DAAs with RBV in treatment naïve and null responder subjects [Time Frame: Post-Treatment Week 24]

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs with RBV versus 3 DAAs with RBV in treatment naïve and null responder subjects [Time Frame: Post-Treatment Week 24]

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with RBV in with different doses of ABT-450/r in treatment treatment naïve and null responder subjects [Time Frame: Post-Treatment Week 24]

Percentage of subjects achieving SVR24 (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with RBV versus 3 DAAs without RBV in treatment naïve subjects [Time Frame: Post-Treatment Week 24]

Secondary ID(s)

2010-022455-31

M11-652

Source(s) of Monetary Support

Please refer to primary and secondary sponsors