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
Verified October 2017 by AbbVie
Information provided by (Responsible Party)
First received: July 28, 2017
Last updated: October 9, 2017
Last Verified: October 2017
History of Changes
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.
Hepatitis C Virus (HCV)
Drug : ABT-493/ABT-530
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 [
- 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.
|Study Start Date:||September 29, 2017|
|Estimated Study Completion Date:||February 18, 2019|
|Estimated Primary Completion Date:||December 5, 2018 (Final data collection date for primary outcome measure)|
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 or 16 weeks.
Tablet; ABT-493 coformulated with ABT-530
|Ages Eligible for Study:||18 Years to 99 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- 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.
Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
Contacts and LocationsChoosing 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
|Contact: AbbVie_Call Centerfirstname.lastname@example.org|
Locations Show More
|Beijing Di Tan Hospital Capital Medical University /ID# 156852||Not yet recruiting|
|Beijing, China, 1000015|
|Peking University People's Hospital /ID# 156851||Not yet recruiting|
|Beijing, China, 100034|
|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||Not yet 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|
|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||Not yet recruiting|
|Shenyang, China, 110006|
|The First Affiliated Hospital of Xinjiang Medical University /ID# 156891||Not yet recruiting|
|Urumqi, China, 830054|
|The First Affiliated Hospital of Xi'an Jiaotong University /ID# 163420||Not yet 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||Not yet recruiting|
|Zhengzhou, China, 450003|
|Korea, Republic of|
|Samsung Medical Center /ID# 163402||Not yet recruiting|
|Seoul, Korea, Republic of, 06351|
Sponsors and CollaboratorsAbbVie
|Study Director:||AbbVie Inc||AbbVie|
|ClinicalTrials.gov Identifier:||NCT03235349 History of Changes|
|Other Study ID Numbers:||M15-593|
|Study First Received:||July 28, 2017|
|Last Updated:||October 9, 2017|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by AbbVie:Human Immunodeficiency Virus
Genotype 1 to 6
Chronic Hepatitis C Virus (HCV)
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.