Clinical Trials

MainTitle

A Study to Evaluate the Efficacy and Safety of 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

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


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT03235349

First received: July 28, 2017
Last updated: July 13, 2018
Last Verified: July 2018
History of Changes
Purpose

Purpose

This is a Phase 3, single-arm, open-label, multicenter study to evaluate the efficacy and safety of ABT-493/ABT-530 in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis 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 : ABT-493/ABT-530
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve 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

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [
Secondary Outcome Measures:
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to 12-16 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 >= 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 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 HCV RNA >= 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 HCV/HIV Co-infected Participants 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: 159
Study Start Date: September 29, 2017
Estimated Study Completion Date: March 8, 2019
Estimated Primary Completion Date: December 5, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: ABT-493/ABT-530
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 or 16 weeks.
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; or
  • 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.
  • Participants must have documented cirrhosis as defined in the protocol.
  • Absence of hepatocellular carcinoma (HCC) as defined in the protocol.
  • 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: NCT03235349

Locations

China
The First Hosp of Jilin Univ /ID# 156825
Changchun, Anhui, China, 130021
Peking Univ first Hospital /ID# 156850
Beijing, Beijing, China, 100034
Peking University Peoples Hospit /ID# 156851
Beijing, Beijing, China, 100044
Guangzhou Eighth People's Hosp /ID# 156865
Guangzhou, Guangdong, China, 510060
Guangdong General Hospital /ID# 156827
Guangzhou, Guangdong, China, 510080
Nanfang Hospital of Southern Medical University /ID# 156866
Guangzhou, Guangdong, China, 510515
3rd Affiliated Hosp Sun Yatsen /ID# 156905
Guangzhou, Guangdong, China, 510630
Jiangsu Province People's Hospital /ID# 156867
Nanjing, Jiangsu, China, 210029
1st Aff Hosp Nanchang Univ /ID# 156908
Nanchang, Jiangxi, China, 330006
Ruijin Hospital, Shanghai Jiaotong /ID# 157337
Shanghai, Shanghai, China, 200025
Huashan Hospital affiliated to Fudan University /ID# 156909
Shanghai, Shanghai, China, 200040
Shanghai Public Health Cli Ctr /ID# 156837
Shanghai, Shanghai, China, 201508
Beijing Di Tan Hosp Cap Med /ID# 156852
Beijing, China, 100015
Beijing Friendship Hospital /ID# 156843
Beijing, China, 100050
Beijing Youan Hosp, Cap Med Un /ID# 163418
Beijing, China, 100069
West China Hospital /ID# 156835
Chengdu, China, 610041
2nd Affiliated Hosp Chongqing /ID# 156838
Chongqing, China, 400010
Mengchao Hepatobiliary Hospita /ID# 156907
Fuzhou, China, 350025
China PLA 81 Hospital /ID# 156868
Nanjing, China, 210002
The Second Hospital of Nanjing /ID# 156869
Nanjing, China, 210003
Shengjing Hosp China Med Univ /ID# 156829
Shenyang, China, 110004
6th People's Hosp Shenyang /ID# 156854
Shenyang, China, 110006
1st Aff Hosp Xinjiang Med Uni /ID# 156891
Urumqi, China, 830054
Fourth Military Medical Univ. /ID# 156767
Xi'an, China, 710038
1st Aff Hos Xi'an Jiaotong Uni /ID# 163420
Xi'an, China, 710061
Henan Provincial Peoples Hosp /ID# 157371
Zhengzhou, Henan, China, 450000
Korea, Republic of
Pusan National University Hosp /ID# 163411
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Seoul National Univ Bundang ho /ID# 163408
Seongnam, Gyeonggido, Korea, Republic of, 13620
Inje University Busan Paik Hospital /ID# 163384
Busan, Gyeongsangbugdo, Korea, Republic of, 47392
Pusan Nat Univ Yangsan Hosp /ID# 163385
Yangsan-si,, Gyeongsangnamdo, Korea, Republic of, 50612
Inha University Hospital /ID# 163381
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Severance Hospital /ID# 163399
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 163402
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 163400
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07345
Korea University Guro Hospital /ID# 163412
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Seoul National University Hospital /ID# 163401
Seoul, Korea, Republic of, 03080
Asan Medical Center /ID# 163398
Seoul, Korea, Republic of, 05505

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc. AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT03235349   History of Changes  
Other Study ID Numbers: M15-593  
Study First Received: July 28, 2017  
Last Updated: July 13, 2018  
Individual Participant Data    
Plan to Share IPD: Yes  

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
Cirrhosis
Compensated Cirrhosis
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
Fibrosis
Liver Cirrhosis
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Coinfection

ClinicalTrials.gov processed this data on September 25, 2018
This information is provided by ClinicalTrials.gov.