Clinical Trials

MainTitle

A 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

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2017 by AbbVie

Sponsor
AbbVie


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

First received: July 28, 2017
Last updated: November 30, 2017
Last Verified: November 2017
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.

Estimated Enrollment: 160
Study Start Date: September 29, 2017
Estimated Study Completion Date: February 26, 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 to 99 Years  
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

Contacts

Contact:   AbbVie_Call Center 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations

China
Beijing Di Tan Hospital Capital Medical University /ID# 156852 Recruiting
Beijing, China, 100015
Peking University First Hospital /ID# 156850 Recruiting
Beijing, China, 100034
Peking University People's Hospital /ID# 156851 Not yet recruiting
Beijing, China, 100034
Beijing Friendship Hospital, Capital Medical University /ID# 156843 Recruiting
Beijing, China, 100050
Beijing Youan Hospital, Capital Medical University /ID# 163418 Recruiting
Beijing, China, 100069
The First Hospital of Jilin University /ID# 156825 Recruiting
Changchun, China, 130021
West China Hospital, Sichuan University /ID# 156835 Recruiting
Chengdu, China, 610041
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 156907 Recruiting
Fuzhou, China, 350025
The Third Affiliated Hospital of Sun Yat-sen University /ID# 156905 Recruiting
Guangzhou, Guangdong Province, China, 510630
Guangzhou Eighth People's Hospital /ID# 156865 Recruiting
Guangzhou, China, 510060
Guangdong General Hospital /ID# 156827 Recruiting
Guangzhou, China, 510080
Nanfang Hospital of Southern Medical University /ID# 156866 Recruiting
Guangzhou, China, 510515
Chinese People's Liberation Army 81 Hospital /ID# 156868 Recruiting
Nanjing, China, 210002
The Second Hospital of Nanjing /ID# 156869 Recruiting
Nanjing, China, 210003
Jiangsu Province Hospital /ID# 156867 Recruiting
Nanjing, China, 210029
Ruijin Hospital, Shanghai Jiaotong Univ, School of Medicine /ID# 157337 Recruiting
Shanghai, China, 200025
Huashan Hospital of Fudan University /ID# 156909 Recruiting
Shanghai, China, 200040
Shanghai Public Health Clinical Center /ID# 156837 Not yet recruiting
Shanghai, China, 200083
Shengjing Hospital of China Medical University /ID# 156829 Recruiting
Shenyang City, China, 110022
The Sixth People's Hospital of Shenyang /ID# 156854 Recruiting
Shenyang, China, 110006
The First Affiliated Hospital of Xinjiang Medical University /ID# 156891 Recruiting
Urumqi, China, 830054
The First Affiliated Hospital of Xi'an Jiaotong University /ID# 163420 Recruiting
Xi'an, Shanxi, China, 710061
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767 Recruiting
Xi'an, China, 710038
Henan Provincial Peoples Hospital /ID# 157371 Recruiting
Zhengzhou, China, 450003
Korea, Republic of
Inje University Busan Paik Hospital /ID# 163384 Not yet recruiting
Busan, Korea, Republic of, 47392
Pusan National University Hospital /ID# 163411 Recruiting
Busan, Korea, Republic of, 49241
Seoul National University Hospital /ID# 163401 Not yet recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital /ID# 163399 Not yet recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center /ID# 163398 Not yet recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center /ID# 163402 Recruiting
Seoul, Korea, Republic of, 06351
Seoul St.Mary Hospital, The Catholic University of Korea /ID# 163400 Not yet recruiting
Seoul, Korea, Republic of, 06591
Korea University Guro Hospital /ID# 163412 Not yet recruiting
Seoul, Korea, Republic of, 08308

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: November 30, 2017  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by AbbVie:

Cirrhosis
Genotype 1 to 6
Chronic Hepatitis C Virus (HCV)
treatment-experienced
Compensated Cirrhosis
co-infection
Human Immunodeficiency Virus
Treatment-naïve
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 December 08, 2017
This information is provided by ClinicalTrials.gov.