ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Status and phase
Completed
Phase 2
Conditions
Hepatitis C Genotype 1
Hepatitis C (HCV)
Chronic Hepatitis C
Treatments
Drug: Ritonavir
Drug: Ribavirin
Drug: ABT-267
Drug: ABT-450
Drug: ABT-333
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).
Full description
A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with HCV. The study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.
Enrollment
580 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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 null-responders to previous treatment with pegylated interferon (pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 HCV RNA decrease at Week 12)
- No evidence of liver cirrhosis
Exclusion criteria
- Significant liver disease with any cause other than HCV as the primary cause
- Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody
- 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
580 participants in 14 patient groups
Group A
Experimental group
Description:
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group B
Experimental group
Description:
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: Ribavirin
Drug: Ritonavir
Group C
Experimental group
Description:
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group D
Experimental group
Description:
Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group E
Experimental group
Description:
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ritonavir
Group F
Experimental group
Description:
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group G
Experimental group
Description:
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group H
Experimental group
Description:
Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group I
Experimental group
Description:
Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group J
Experimental group
Description:
Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group K
Experimental group
Description:
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group L
Experimental group
Description:
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group M
Experimental group
Description:
Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Group N
Experimental group
Description:
Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
Treatment:
Drug: ABT-450
Drug: ABT-333
Drug: ABT-267
Drug: Ribavirin
Drug: Ritonavir
Trial contacts and locations
97
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Data sourced from clinicaltrials.gov
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