Clinical Trials

MainTitle

A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

This study is ongoing, but not recruiting participants.
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT03222583

First received: July 17, 2017
Last updated: May 31, 2018
Last Verified: May 2018
History of Changes
Purpose

Purpose

A Phase 3, double-blind (DB), placebo-controlled study to evaluate the efficacy and safety of ABT-493/ABT-530 in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve 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.

Condition Intervention Phase
Hepatitis C Virus (HCV)

Drug : Placebo
Drug : ABT-493/ABT-530
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Arm A HCV GT2-Infected Participants Achieving SVR12 [ Time Frame: 12 weeks after the last dose of study drug ]
    SVR12 was defined as plasma HCV RNA level less than the LLOQ 12 weeks after the last actual dose of study drug
  • Percentage of Arm A HCV genotype (GT)1-6 Infected Participants Achieving SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    Sustained Virologic Response 12 Weeks Post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
  • Percentage of Arm A HCV GT1-Infected Participants Achieving SVR12 [ Time Frame: 12 weeks after last does of study drug ]
    SVR12 was defined as plasma HCV RNA level less than LLOQ 12 weeks after the last dose of study drug.
Secondary Outcome Measures:
  • Percentage of Participants in Arm A 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 HCV RNA greater than or equal to the 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 excluding reinfection.
  • Percentage of Participants in Arm A With On-treatment Virologic Failure [ Time Frame: Up to 8-16 weeks while on treatment ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < LLOQ during treatment, or with quantifiable HCV RNA at end of treatment with at least 6 weeks of treatment.
  • Percentage of HCV/HIV Co-infected Participants in Arm A Achieving SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma HCV RNA level less than LLOQ 12 weeks after the last dose of study drug.

Enrollment: 535
Study Start Date: October 4, 2017
Estimated Study Completion Date: March 1, 2019
Estimated Primary Completion Date: October 12, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm A DB Active Drug
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 or 16 weeks (double-blind [DB] treatment period)
Drug: ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Other Name: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir
Experimental: Arm B DB Placebo then OL Active Drug
Placebo for ABT-493/ABT-530 QD for 8 or 16 weeks (DB treatment period) followed by ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 or 16 weeks (open-label [OL] treatment period)
Drug: Placebo

Tablet; matching placebo

Drug: ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Other Name: ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • 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 OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed >= 8 weeks prior to screening.
  • Participant must be documented as non-cirrhotic.
  • 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 CD4+ count greater than or equal to 500 cells/mm3 (or CD4+ % >= 29%)
  • 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 Criteria:
  • 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 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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03222583

Locations

China
The First Hosp of Jilin Univ
Changchun, Anhui, China, 130021
Nanfang Hosp Southern Med Univ
Guangzhou, Anhui, China, 510000
Peking University Peoples Hospit
Beijing, Beijing, China, 100044
Guangzhou Eighth People's Hosp
Guangzhou, Guangdong, China, 510060
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
3rd Affiliated Hosp Sun Yatsen
Guangzhou, Guangdong, China, 510630
Jiangsu Province People's Hospital
Nanjing, Jiangsu, China, 210029
Shanghai Changzheg Hospital
Shanghai, Shanghai, China, 200003
Ruijin Hospital, Shanghai Jiaotong
Shanghai, Shanghai, China, 200025
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai, China, 200040
Shanghai Public Health Cli Ctr
Shanghai, Shanghai, China, 201508
Beijing Di Tan Hosp Cap Med
Beijing, China, 100015
302 Military Hospital Of China
Beijing, China, 100039
Beijing Friendship Hospital
Beijing, China, 100050
Beijing Youan Hosp, Cap Med Un
Beijing, China, 100069
Xiangya Hosp Central South Uni
Changsha, China, 410008
West China Hospital
Chengdu, China, 610041
2nd Affiliated Hosp Chongqing
Chongqing, China, 400010
1st Affiliated Hosp 3rd Milita
Chongqing, China, 400038
Dalian Sixth Peoples Hospital
Dalian, China, 116031
Mengchao Hepatobiliary Hospita
Fuzhou, China, 350025
Hainan General Hospital
Haikou, Hainan, China, 570311
The Affil Hosp of Beihua Univ
Jilin, China, 132011
Jinan Infectious Diseases Hosp
Jinan, Shandong, China, 250021
First Affiliated Hosp of Kunmi
Kunming, China, 650032
China PLA 81 Hospital
Nanjing, China, 210002
The Second Hospital of Nanjing
Nanjing, China, 210003
Shengjing Hosp China Med Univ
Shenyang, China, 110004
6th People's Hosp Shenyang
Shenyang, China, 110006
Tianjin Third Central Hospital
Tianjin, China, 300170
1st Aff Hosp Xinjiang Med Uni
Urumqi, China, 830054
Union Hosp, Tongji Med College
Wuhan, China, 430022
Tongji Hosp Tongji Med College
Wuhan, China, 430030
Fourth Military Medical Univ.
Xi'an, China, 710038
1st Aff Hos Xi'an Jiaotong Uni
Xi'an, China, 710061
Henan Provincial Peoples Hosp
Zhengzhou, Henan, China, 450000
Korea, Republic of
Pusan National University Hosp
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Seoul National Univ Bundang ho
Seongnam, Gyeonggido, Korea, Republic of, 13620
Pusan Nat Univ Yangsan Hosp
Yangsan-si,, Gyeongsangnamdo, Korea, Republic of, 50612
Inha University Hospital
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Severance Hospital, Yonsei University Health System
Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of, 03722
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
Asan Medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Cath Univ Seoul St Mary's Hosp
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Korea Universtiy Guro Hospital
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Inje Univ Busan Paik Hosp
Busan, Korea, Republic of, 614-735
Singapore
National University Hospital (
Singapore, Singapore, 119228
Singapore General Hospital
Singapore, Singapore, 169608
Changi General Hospital
Singapore, Singapore, 529889

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT03222583   History of Changes  
Other Study ID Numbers: M15-592  
Study First Received: July 17, 2017  
Last Updated: May 31, 2018  
Individual Participant Data    
Plan to Share IPD: Undecided  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Keywords provided by AbbVie:

Chronic Hepatitis C Virus (HCV)
Genotype 1 to 6
Asian
non-cirrhotic
Human Immunodeficiency Virus
co-infection
Treatment-naïve
Treatment-experienced
interferon

Additional relevant MeSH terms:
Infection
Hepatitis
Hepatitis A
Virus Diseases
Hepatitis C
Hepatitis, Chronic
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Coinfection

ClinicalTrials.gov processed this data on July 23, 2018
This information is provided by ClinicalTrials.gov.