A Phase 3 interventional study of ABT-450/r/ABT-267, ABT-333 and Ribavirin in Chronic Hepatitis C Infection, sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
A randomized, double-blind, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naïve, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 419 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
Drug: ABT-450/r/ABT-267, ABT-333 · Drug: Ribavirin
ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
Drug: ABT-450/r/ABT-267, ABT-333 · Drug: Placebo for ribavirin
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Also known as: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAK
Capsule
Capsule
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate
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. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV
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. The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \< LLN at the end of treatment.
Time frame: Baseline (Day 1) and Week 12 (End of Treatment)
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate
The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV.
Time frame: 12 weeks after last dose of study drug
Percentage of Participants With Virologic Failure During Treatment
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 \[2 consecutive HCV RNA measurements \> 1 log10 IU/mL above the lowest value post baseline\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).
Time frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
Percentage of Participants With Virologic Relapse After Treatment
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
Time frame: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)
| Milestone | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Started | 210 | 209 |
| Completed | 208 | 207 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
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. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).
| percentage of participants | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate | 99.5 | 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. The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
| percentage of participants | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV | 99.5 | 100 |
The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \< LLN at the end of treatment.
| percentage of participants | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment | 51.2 | 3.4 |
The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV.
| percentage of particpants | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate | 99.5 | 100 |
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 \[2 consecutive HCV RNA measurements \> 1 log10 IU/mL above the lowest value post baseline\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment).
| percentage of participants | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Rebound | 0.5 | 0 |
| Failure to suppress | 0 | 0 |
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
| percentage of participants | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| Percentage of Participants With Virologic Relapse After Treatment | 0 | 0 |
Collected over AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | — | 4/210 (1.9%) | 133/210 (63.3%) |
| ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | — | 4/209 (1.9%) | 97/209 (46.4%) |
| Event | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| ARTHRITISMusculoskeletal and connective tissue disorders | 0/210 | 1/209 |
| MYALGIAMusculoskeletal and connective tissue disorders | 0/210 | 1/209 |
| INTRADUCTAL PROLIFERATIVE BREAST LESIONNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/210 | 1/209 |
| UTERINE POLYPReproductive system and breast disorders | 0/210 | 1/209 |
| ATRIAL FIBRILLATIONCardiac disorders | 1/210 | 0/209 |
| CORONARY ARTERY DISEASECardiac disorders | 1/210 | 0/209 |
| NEPHROLITHIASISRenal and urinary disorders | 1/210 | 0/209 |
| EPIDIDYMITISReproductive system and breast disorders | 1/210 | 0/209 |
| Event | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV |
|---|---|---|
| HEADACHENervous system disorders | 51/210 | 49/209 |
| FATIGUEGeneral disorders | 45/210 | 49/209 |
| PRURITUSSkin and subcutaneous tissue disorders | 25/210 | 11/209 |
| NAUSEAGastrointestinal disorders | 23/210 | 9/209 |
| ASTHENIAGeneral disorders | 22/210 | 12/209 |
| INSOMNIAPsychiatric disorders | 19/210 | 7/209 |
| COUGHRespiratory, thoracic and mediastinal disorders | 19/210 | 5/209 |
| ANAEMIABlood and lymphatic system disorders | 14/210 | 1/209 |
| DYSPEPSIAGastrointestinal disorders | 14/210 | 9/209 |
| DIARRHOEAGastrointestinal disorders | 9/210 | 13/209 |
All randomized participants who received at least 1 dose of study drug
| Age, Continuous(years) | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | Total |
|---|---|---|---|
| Mean | 48.4 ± 11.94 | 49.2 ± 12.03 | 48.8 ± 11.98 |
| Sex: Female, Male(Participants) | ABT-450/r/ABT-267 and ABT-333, Plus RBV | ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV | Total |
|---|---|---|---|
| Female | 104 | 123 | 227 |
| Male | 106 | 86 | 192 |
No study locations are listed for this record.
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)