Status:
COMPLETED
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
Lead Sponsor:
AbbVie
Conditions:
Hepatitis C Virus (HCV)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cir...
Eligibility Criteria
Inclusion
- Must be of Asian descent.
- Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
- Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL at Screening Visit.
- Chronic HCV infection defined as one of the following:
- Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
- A liver biopsy consistent with chronic HCV infection;
- HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon \[pegIFN\] with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed \>= 8 weeks prior to screening.
- Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening and no current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites noted on physical exam, bleeding varices, use of diuretics for ascites, or hepatic encephalopathy.
- Absence of hepatocellular carcinoma (HCC)
- Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:
- Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening.
- Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ % \>= 29%), or
- On a stable, qualifying HIV-1 ART regimen with CD4+ count \>= 200 cells/mm³ (or CD4+ % \>= 14%) at Screening; and plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.
Exclusion
- Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.
- Any cause of liver disease other than chronic HCV-infection.
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype
- Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
- Chronic human immunodeficiency virus, type 2 (HIV-2) infection
- Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
- For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
- Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening
- Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03235349
Start Date
September 29 2017
End Date
February 25 2019
Last Update
November 21 2019
Active Locations (34)
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1
Peking University Peoples Hospit /ID# 156851
Beijing, Beijing Municipality, China, 100044
2
Guangzhou Eighth People's Hosp /ID# 156865
Guangzhou, Guangdong, China, 510060
3
Guangdong General Hospital /ID# 156827
Guangzhou, Guangdong, China, 510080
4
Nanfang Hospital of Southern Medical University /ID# 156866
Guangzhou, Guangdong, China, 510515