- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243280
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
July 9, 2021 updated by: AbbVie
An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6).
Although RBV was initially planned in the protocol, it was not administered in any of the study arms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study consisted of two independent parts: Part 1 was conducted first followed by Part 2. Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled participants who received ABT-493 and ABT-530 for 8 or 12 weeks.
Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV RNA to evaluate efficacy and the emergence and persistence of viral variants.
Study Type
Interventional
Enrollment (Actual)
174
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female between 18 and 70 years of age, inclusive, at time of screening
- Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and 2) or GT4, GT5, or GT6 (Study Part 2) infection
Chronic HCV infection defined as one of the following:
- Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or
- Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic HCV infection)
Participant had to meet one of the following criteria:
- Treatment-naïve: participant had never received treatment for HCV infection
- Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or prior relapse) (for Study Part 2)
- Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only), per local standard
Exclusion Criteria:
- History of severe, life-threatening or other significant sensitivity to any drug
- Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator
- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- Hepatitis C virus (HCV) genotype performed during screening indicating co-infection with more than one HCV genotype
- Any cause of liver disease other than chronic HCV infection
- Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or unquantifiable or undetectable HCV RNA at screening
- Previous use of an HCV direct-acting antiviral agent (DAA)
- Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects only)
- For participants in Study Part 2 who were enrolling with compensated cirrhosis: past clinical evidence of Child-Pugh B or C Classification (score of > 6) or clinical history of liver decompensation, including ascites (noted on physical exam), bleeding varices, use of beta-blockers for portal hypertension or ascites, or hepatic encephalopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm B
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm C
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm D
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm E
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm F
ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm G
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm H
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm I
ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm J
ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
|
Tablet
Other Names:
Tablet
Other Names:
|
Experimental: Arm K
ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
|
Tablet
Other Names:
Tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
Time Frame: 12 weeks after the last actual dose of study drug
|
The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
|
12 weeks after the last actual dose of study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment
Time Frame: 4 weeks after the last actual dose of study drug
|
The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
|
4 weeks after the last actual dose of study drug
|
Percentage of Participants With On-treatment Virologic Failure
Time Frame: Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment
|
The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
|
Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment
|
Percentage of Participants With Post-treatment Relapse
Time Frame: From the end of treatment through 12 weeks after the last dose of study drug
|
Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
|
From the end of treatment through 12 weeks after the last dose of study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.
- Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.
- Naganuma A, Chayama K, Notsumata K, Gane E, Foster GR, Wyles D, Kwo P, Crown E, Bhagat A, Mensa FJ, Otani T, Larsen L, Burroughs M, Kumada H. Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. J Gastroenterol. 2019 Aug;54(8):752-761. doi: 10.1007/s00535-019-01569-7. Epub 2019 Mar 13.
- Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.
- Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.
- Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, Felizarta F, Sulkowski MS, Gane E, Maliakkal B, Overcash JS, Gordon SC, Muir AJ, Aguilar H, Agarwal K, Dore GJ, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017 Aug;67(2):263-271. doi: 10.1016/j.jhep.2017.03.039. Epub 2017 Apr 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
September 4, 2014
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimate)
September 17, 2014
Study Record Updates
Last Update Posted (Actual)
July 13, 2021
Last Update Submitted That Met QC Criteria
July 9, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
- HCV
- glecaprevir
- pibrentasvir
- Chronic Hepatitis C
- Child Pugh A
- Hepatitis C virus
- Compensated Cirrhosis
- Hepatitis C
- Cirrhotic
- Ribavirin
- RBV
- HCV GT1
- Hepatitis C Genotype 1 (GT1)
- IFN free
- Interferon (IFN) Free
- HCV GT4
- HCV GT5
- HCV GT6
- Hepatitis C Genotype 4 (GT 4)
- Hepatitis C Genotype 5 (GT 5)
- Hepatitis C Genotype 6 (GT 6)
- ABT-493
- ABT-530
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
Other Study ID Numbers
- M14-867
- 2014-002925-36 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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