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A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)

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AbbVie

Status and phase

Completed
Phase 2

Conditions

Compensated Cirrhosis
Hepatitis C Virus
Chronic Hepatitis C

Treatments

Drug: Ribavirin (RBV)
Drug: ABT-493
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-530

Study type

Interventional

Funder types

Industry

Identifiers

NCT01995071
M13-595

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.

Enrollment

89 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic HCV infection prior to study enrollment.
  • Screening laboratory result indicating HCV genotype 1-infection.
  • Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.
  • Per local standard, subject is considered to be non-cirrhotic or to have compensated cirrhosis.

Exclusion criteria

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus antibody (HIV Ab).
  • Prior therapy for the treatment of HCV.
  • Any current or past clinical evidence of Child Pugh B or C classification of clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.
  • Any cause of liver disease other than chronic HCV infection.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

89 participants in 12 patient groups

Arm 1 Non-cirrhotic
Experimental group
Description:
ABT-493 Dose A (100 mg once daily \[QD\]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-493
Arm 2 Non-cirrhotic
Experimental group
Description:
ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-493
Arm 3 Non-cirrhotic
Experimental group
Description:
ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-493
Arm 4 Non-cirrhotic
Experimental group
Description:
ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-493
Arm 5 Compensated cirrhotic
Experimental group
Description:
ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-493
Arm 6 Non-cirrhotic
Experimental group
Description:
ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Arm 7 Non-cirrhotic
Experimental group
Description:
ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Arm 8 Non-cirrhotic
Experimental group
Description:
ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Arm 9 Non-cirrhotic
Experimental group
Description:
ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Arm 10 Compensated cirrhotic
Experimental group
Description:
ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333
Arm 11 Non-cirrhotic
Experimental group
Description:
ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267, ABT-333
Drug: ABT-493
Arm 12 Non-cirrhotic
Experimental group
Description:
ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Treatment:
Drug: Ribavirin (RBV)
Drug: ABT-530
Drug: ABT-450/r/ABT-267, ABT-333

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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