A Phase 2 interventional study of ABT-450/r and ABT-267 in Hepatitis C, Chronic, sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.
This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis. Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other groups completed the study.
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 316 is above the median of 90 across 789 interventional studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 223 studies on the registry; none are open to participants now.
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Subjects must meet one of the following:
Exclusion Criteria:
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Drug: ABT-450/r · Drug: ABT-267
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
Drug: ABT-450/r · Drug: ABT-267
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
Drug: ABT-450/r · Drug: ABT-267
ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Drug: ABT-450/r · Drug: ABT-267 · Drug: Ribavirin (RBV)
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants
Drug: ABT-450/r · Drug: ABT-267
ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if \< 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
Drug: ABT-450/r · Drug: ABT-267 · Drug: Ribavirin (RBV)
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
Drug: ABT-450/r · Drug: ABT-267
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Drug: ABT-450/r · Drug: ABT-267
Tablet; ABT-450; Capsule; ritonavir
Also known as: ABT-450 also known as paritaprevir
Tablet
Also known as: ABT-267 also known as ombitasvir
Tablet
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 24 weeks after the last dose of study drug.
Time frame: 24 weeks after the last actual dose of study drug
Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).
Time frame: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment.
Time frame: Within 12 weeks after the last dose of study drug
Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.
Time frame: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.
| Milestone | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| Started | 44 | 42 | 40 | 42 | 49 | 47 | 52 |
| Completed study drug | 42 | 40 | 39 | 42 | 49 | 43 | 52 |
| Completed | 40 | 39 | 40 | 41 | 49 | 44 | 52 |
| Not completed | 4 | 3 | 0 | 1 | 0 | 3 | 0 |
| Withdrew: Lost to follow-up | 3 | 3 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Adverse event and withdrew consent | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Patient's decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 24 weeks after the last dose of study drug.
| Percentage of participants | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment | 86.4 (72.6 to 94.8) | 92.9 (80.5 to 98.5) | 90.0 (76.3 to 97.2) | 100.0 (91.6 to 100.0) | 100.0 (92.7 to 100.0) | 97.9 (88.7 to 99.9) | 98.1 (89.7 to 100.0) |
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\<LLOQ\]) 12 weeks after the last dose of study drug.
| Percentage of participants | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment | 90.9 (78.3 to 97.5) | 95.2 (83.8 to 99.4) | 90.0 (76.3 to 97.2) | 100 (91.6 to 100.0) | 100 (92.7 to 100.0) | 97.9 (88.7 to 99.9) | 98.1 (89.7 to 100.0) |
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).
| Percentage of participants | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure. | 2.3 (0.1 to 12.0) | 0 (0.0 to 8.4) | 2.5 (0.1 to 13.2) | 0 (0.0 to 8.4) | 0 (0.0 to 7.3) | 0 (0.0 to 7.5) | 0 (0.0 to 6.8) |
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment.
| Percentage of participants | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse. | 4.8 (0.6 to 16.2) | 0 (0.0 to 8.8) | 7.7 (1.6 to 20.9) | 0 (0.0 to 8.4) | 0 (0.0 to 7.3) | 0 (0.0 to 8.0) | 1.9 (0.0 to 10.3) |
Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.
| Percentage of participants | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events | 77.3 | 73.8 | 80.0 | 88.1 | 85.7 | 85.1 | 71.2 |
Collected over Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 2/44 (4.5%) | 30/44 (68.2%) |
| Group 2 | — | 1/42 (2.4%) | 24/42 (57.1%) |
| Group 3 | — | 1/40 (2.5%) | 26/40 (65%) |
| Group 4 | — | 0/42 (0%) | 32/42 (76.2%) |
| Group 6 | — | 0/49 (0%) | 38/49 (77.6%) |
| Group 7 | — | 3/47 (6.4%) | 34/47 (72.3%) |
| Group 8 | — | 2/52 (3.8%) | 33/52 (63.5%) |
| Event | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| DEVICE EXTRUSIONGeneral disorders | 0/44 | 0/42 | 1/40 | 0/42 | 0/49 | 0/47 | 0/52 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASERespiratory, thoracic and mediastinal disorders | 0/44 | 1/42 | 0/40 | 0/42 | 0/49 | 0/47 | 0/52 |
| ATRIAL FIBRILLATIONCardiac disorders | 1/44 | 0/42 | 0/40 | 0/42 | 0/49 | 0/47 | 0/52 |
| CONTUSIONInjury, poisoning and procedural complications | 1/44 | 0/42 | 0/40 | 0/42 | 0/49 | 0/47 | 0/52 |
| ROAD TRAFFIC ACCIDENTInjury, poisoning and procedural complications | 1/44 | 0/42 | 0/40 | 0/42 | 0/49 | 0/47 | 0/52 |
| OESOPHAGEAL VARICES HAEMORRHAGEGastrointestinal disorders | 0/44 | 0/42 | 0/40 | 0/42 | 0/49 | 1/47 | 0/52 |
| ALANINE AMINOTRANSFERASE INCREASEDInvestigations | 0/44 | 0/42 | 0/40 | 0/42 | 0/49 | 1/47 | 0/52 |
| ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations | 0/44 | 0/42 | 0/40 | 0/42 | 0/49 | 1/47 | 0/52 |
| HEPATIC NEOPLASMNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/44 | 0/42 | 0/40 | 0/42 | 0/49 | 1/47 | 0/52 |
| HUMERUS FRACTUREInjury, poisoning and procedural complications | 0/44 | 0/42 | 0/40 | 0/42 | 0/49 | 0/47 | 1/52 |
| Event | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 |
|---|---|---|---|---|---|---|---|
| HEADACHENervous system disorders | 13/44 | 14/42 | 10/40 | 14/42 | 14/49 | 9/47 | 10/52 |
| ASTHENIAGeneral disorders | 11/44 | 3/42 | 2/40 | 10/42 | 16/49 | 10/47 | 7/52 |
| NAUSEAGastrointestinal disorders | 4/44 | 8/42 | 0/40 | 7/42 | 6/49 | 5/47 | 5/52 |
| FATIGUEGeneral disorders | 3/44 | 6/42 | 0/40 | 5/42 | 9/49 | 4/47 | 6/52 |
| PRURITUSSkin and subcutaneous tissue disorders | 2/44 | 6/42 | 0/40 | 1/42 | 5/49 | 8/47 | 9/52 |
| DRY SKINSkin and subcutaneous tissue disorders | 0/44 | 7/42 | 0/40 | 0/42 | 3/49 | 1/47 | 0/52 |
| INSOMNIAPsychiatric disorders | 2/44 | 1/42 | 0/40 | 4/42 | 8/49 | 3/47 | 4/52 |
| DIARRHOEAGastrointestinal disorders | 2/44 | 6/42 | 0/40 | 6/42 | 3/49 | 7/47 | 7/52 |
| HYPERTENSIONVascular disorders | 0/44 | 0/42 | 1/40 | 1/42 | 1/49 | 7/47 | 1/52 |
| IRRITABILITYGeneral disorders | 3/44 | 0/42 | 0/40 | 6/42 | 2/49 | 1/47 | 0/52 |
All participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 48.9 ± 10.0 | 55.8 ± 6.9 | 54.2 ± 9.6 | 44.2 ± 12.7 | 50.9 ± 10.1 | 57.8 ± 7.1 | 57.1 ± 6.0 | 52.8 ± 10.1 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Group 3 | Group 4 | Group 6 | Group 7 | Group 8 | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 20 | 17 | 25 | 14 | 13 | 24 | 19 | 132 |
| Male | 24 | 25 | 15 | 28 | 36 | 23 | 33 | 184 |
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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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AbbVie (prior sponsor, Abbott) →