NCT01609933

A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study

An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 71 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who did not respond to treatment in a previous AbbVie/Abbott combination study.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	ABT-450/r	ABT-450 (tablets) dosed with ritonavir (capsules or tablets)
DRUG	ABT-267	ABT-267 (tablets)
DRUG	pegylated interferon alpha-2a (pegIFN)	pegIFN alpha-2a (syringe)
DRUG	Ribavirin (RBV)	Ribavirin (tablets)

Timeline

• Start date: 2012-12-18
• Primary completion: 2017-05-03
• Completion: 2017-05-03
• First posted: 2012-06-01
• Last updated: 2018-06-19
• Results posted: 2018-06-19

Regulatory

• FDA-regulated drug study