A Phase 3 interventional study of ABT-493/ABT-530 in Hepatitis C Virus Infection, Chronic Hepatitis C and Compensated Cirrhosis, sponsored by AbbVie. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 146 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Drug: ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Also known as: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) 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 HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time frame: Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment
Percentage of Participants With Post-treatment Relapse
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.
Time frame: From the end of treatment through 12 weeks after the last dose of study drug
| Milestone | ABT-493/ABT-530 |
|---|---|
| Started | 146 |
| Completed | 138 |
| Not completed | 8 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrew consent | 1 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Other | 3 |
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug.
| percentage of participants | ABT-493/ABT-530 |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 99.3 (98.0 to 100.0) |
On-treatment virologic failure was defined as confirmed increase of \> 1 log(subscript)10(subscript) 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 HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
| percentage of participants | ABT-493/ABT-530 |
|---|---|
| Percentage of Participants With On-treatment Virologic Failure | 0.0 (0.0 to 2.6) |
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 participants | ABT-493/ABT-530 |
|---|---|
| Percentage of Participants With Post-treatment Relapse | 0.7 (0.1 to 3.8) |
Collected over Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT-493/ABT-530 | — | 11/146 (7.5%) | 63/146 (43.2%) |
| Event | ABT-493/ABT-530 |
|---|---|
| HEPATOCELLULAR CARCINOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/146 |
| GASTRIC ULCERGastrointestinal disorders | 1/146 |
| OESOPHAGEAL VARICES HAEMORRHAGEGastrointestinal disorders | 1/146 |
| ENDOPHTHALMITISInfections and infestations | 1/146 |
| RECTAL ABSCESSInfections and infestations | 1/146 |
| URINARY TRACT INFECTIONInfections and infestations | 1/146 |
| TUMOUR MARKER INCREASEDInvestigations | 1/146 |
| HYPERGLYCAEMIAMetabolism and nutrition disorders | 1/146 |
| HYPOGLYCAEMIAMetabolism and nutrition disorders | 1/146 |
| SYNCOPENervous system disorders | 1/146 |
| Event | ABT-493/ABT-530 |
|---|---|
| FATIGUEGeneral disorders | 27/146 |
| HEADACHENervous system disorders | 20/146 |
| PRURITUSSkin and subcutaneous tissue disorders | 14/146 |
| NAUSEAGastrointestinal disorders | 13/146 |
| DIARRHOEAGastrointestinal disorders | 12/146 |
| URINARY TRACT INFECTIONInfections and infestations | 9/146 |
| Age, Continuous(years) | ABT-493/ABT-530 |
|---|---|
| Mean | 60.12 ± 10.43 |
| Sex: Female, Male(Participants) | ABT-493/ABT-530 |
|---|---|
| Female | 56 |
| Male | 90 |
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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