Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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) ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Males and females at least 18 years old at screening
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
- Chronic hepatitis C, genotype 1 infection
- Males must be surgically sterile or agree to practice acceptable forms of birth control
- Screening laboratory result indicating HCV genotype 1 infection
Exclusion
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
- Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
- Confirmed presence of hepatocellular carcinoma
- History of solid organ transplant
Key Trial Info
Start Date :
October 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2021
Estimated Enrollment :
1596 Patients enrolled
Trial Details
Trial ID
NCT02219490
Start Date
October 30 2014
End Date
May 13 2021
Last Update
April 7 2023
Active Locations (187)
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1
CHU Bab El Oued /ID# 145420
Algiers, Algeria, 16000
2
CHU Bologhine Hospital /ID# 145421
Algiers, Algeria, 16000
3
CHU Mustapha Bacha /ID# 132130
Algiers, Algeria, 16000
4
St Vincent's Hospital Sydney /ID# 131001
Darlinghurst, New South Wales, Australia, 2010