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A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

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AbbVie

Status and phase

Completed
Phase 3

Conditions

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02219490
2014-001022-14 (EudraCT Number)
M14-423

Details and patient eligibility

About

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Full description

This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Enrollment

1,596 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Males and females at least 18 years old at screening
  2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
  3. Chronic hepatitis C, genotype 1 infection
  4. Males must be surgically sterile or agree to practice acceptable forms of birth control
  5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion criteria

  1. Use of contraindicated medications within 2 weeks of dosing
  2. Abnormal laboratory tests
  3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
  4. Confirmed presence of hepatocellular carcinoma
  5. History of solid organ transplant

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,596 participants in 1 patient group

ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
Experimental group
Description:
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
Treatment:
Drug: ABT-333
Drug: Ribavirin (RBV)
Drug: ABT-450/r/ABT-267

Trial documents
2

Trial contacts and locations

187

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Data sourced from clinicaltrials.gov

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