Chronic Hepatitis C Clinical Trial
Official title:
A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy
| Verified date | January 2017 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.
| Status | Completed |
| Enrollment | 141 |
| Est. completion date | January 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. Previous treatment with DAA-containing regimen for chronic HCV infection resulting in either on-treatment virologic failure or post-treatment relapse 2. Chronic HCV GT 1, 4, 5, or 6-infection Exclusion Criteria: 1. History of severe, life-threatening or other significant sensitivity to any drug 2. 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 3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol 4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) 5. Co-infection with more than one HCV genotype |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Site Reference ID/Investigator# 142441 | Adelaide | |
| Australia | Site Reference ID/Investigator# 148121 | Clayton | |
| Australia | Site Reference ID/Investigator# 149250 | Westmead | |
| France | Site Reference ID/Investigator# 147726 | Creteil | |
| France | Site Reference ID/Investigator# 147729 | Paris Cedex 14 | |
| New Zealand | Site Reference ID/Investigator# 148122 | Grafton | |
| Puerto Rico | Site Reference ID/Investigator# 145954 | Ponce | |
| Puerto Rico | Site Reference ID/Investigator# 146074 | San Juan | |
| Spain | Site Reference ID/Investigator# 147953 | Barcelona | |
| Spain | Site Reference ID/Investigator# 147956 | Barcelona | |
| Spain | Site Reference ID/Investigator# 147954 | Majadahonda | |
| United Kingdom | Site Reference ID/Investigator# 147534 | Glasgow | |
| United States | Site Reference ID/Investigator# 148654 | Arlington | Texas |
| United States | Site Reference ID/Investigator# 137125 | Bakersfield | California |
| United States | Site Reference ID/Investigator# 137138 | Baltimore | Maryland |
| United States | Site Reference ID/Investigator# 140886 | Chapel Hill | North Carolina |
| United States | Site Reference ID/Investigator# 140885 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 137133 | DeLand | Florida |
| United States | Site Reference ID/Investigator# 137129 | Dothan | Alabama |
| United States | Site Reference ID/Investigator# 137142 | Germantown | Tennessee |
| United States | Site Reference ID/Investigator# 148624 | Lynchburg | Virginia |
| United States | Site Reference ID/Investigator# 139621 | Manhasset | New York |
| United States | Site Reference ID/Investigator# 137127 | Novi | Michigan |
| United States | Site Reference ID/Investigator# 137141 | Poughkeepsie | New York |
| United States | Site Reference ID/Investigator# 137228 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 137128 | San Diego | California |
| United States | Site Reference ID/Investigator# 137131 | San Francisco | California |
| United States | Site Reference ID/Investigator# 148603 | Santa Fe | New Mexico |
| United States | Site Reference ID/Investigator# 137130 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 141017 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 141937 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 137122 | Shreveport | Louisiana |
| United States | Site Reference ID/Investigator# 137137 | Statesville | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Australia, France, New Zealand, Puerto Rico, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with sustained virologic response (SVR) 12 | Hepatitis C virus ribonucleic acid level less than the lower limit of quantification | 12 weeks after last dose of study drug | |
| Secondary | Percentage of participants with sustained virologic response (SVR) 4 | Hepatitis C virus ribonucleic acid level less than the lower limit of quantification | 4 weeks after last dose of study drug | |
| Secondary | Percentage of participants with virologic failure during treatment | Percentage of participants with quantifiable hepatitis C virus ribonucleic acid (HCV RNA) levels at the end of treatment, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA levels during treatment. | Tested minimally every 2 weeks up to last dose of study drug | |
| Secondary | Percentage of participants with Post-Treatment relapse | Percentage of participants with confirmed quantifiable hepatitis C virus ribonucleic acid (HCV RNA) levels after completion of treatment among participants with unquantifiable HCV RNA at the end of treatment. | Within 12 weeks after the last dose of study drug |
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|---|---|---|---|
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