A Phase 2 interventional study of ABT-450 and ABT-072 in Hepatitis C, HCV and Chronic Hepatitis C Infection, sponsored by AbbVie (prior sponsor, Abbott). Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-01-08.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.
This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 11 is below the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 223 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
Drug: ABT-450 · Drug: ABT-072 · Drug: Ribavirin · Drug: Ritonavir
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).
Time frame: Week 4 through Week 12
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.
Time frame: Week 2
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).
Time frame: Week 4
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug.
Time frame: Post-treatment Day 1 to Post-treatment Week 12
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; \< 25 IU/mL) 24 weeks after the last dose of study drug.
Time frame: Post-treatment Day 1 to Post-treatment Week 24
Time to Failure to Suppress or Rebound During Treatment
The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA \<LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA \> lower limit of detection (LLOD) for participants who previously achieved HCV RNA \< LLOD.
Time frame: Day 1 through Week 12
Time to Virologic Relapse Through 24 Weeks Post-treatment
Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA \< LLOQ at the end of treatment.
Time frame: Post-treatment Day 1 to Post-treatment Week 24
| Milestone | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).
| percentage of participants | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 | 100 |
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2.
| percentage of participants | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 |
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL).
| percentage of participants | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 | 100 |
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug.
| percentage of participants | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 90.9 |
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; \< 25 IU/mL) 24 weeks after the last dose of study drug.
| percentage of participants | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 90.9 |
The time to failure to suppress was defined as first day a participant met any virologic stopping criteria during treatment. The virologic stopping criteria also includes failure to achieve a 2 log10 IU/mL decrease in HCV RNA by Week 1, failure to achieve HCV RNA \<LLOQ by Week 6, or rebound, defined as first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value) or confirmed HCV RNA \> lower limit of detection (LLOD) for participants who previously achieved HCV RNA \< LLOD.
| Days | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Time to Failure to Suppress or Rebound During Treatment | NA ± NA |
Time to confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ lower limit of quantitation (LLOQ) (2 consecutive measurements ≥ LLOQ) at any point in the post-treatment period among participants with HCV RNA \< LLOQ at the end of treatment.
| Days | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Time to Virologic Relapse Through 24 Weeks Post-treatment | 84 ± NA |
Collected over Adverse Events were collected from the time of study drug administration to 30 days after last dose of study drug (up to 16 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT-450/r and ABT-072, Plus Ribavirin (RBV) | — | 0/11 (0%) | 11/11 (100%) |
| Event | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| HEADACHENervous system disorders | 4/11 |
| NAUSEAGastrointestinal disorders | 3/11 |
| FATIGUEGeneral disorders | 3/11 |
| DRY SKINSkin and subcutaneous tissue disorders | 3/11 |
| GASTROOESOPHAGEAL REFLUX DISEASEGastrointestinal disorders | 2/11 |
| RASHSkin and subcutaneous tissue disorders | 2/11 |
| VERTIGOEar and labyrinth disorders | 1/11 |
| VISUAL ACUITY REDUCEDEye disorders | 1/11 |
| ABDOMINAL DISCOMFORTGastrointestinal disorders | 1/11 |
| ABDOMINAL PAINGastrointestinal disorders | 1/11 |
Baseline analyses included all participants.
| Age, Continuous(years) | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Mean | 56.4 ± 7.35 |
| Sex: Female, Male(Participants) | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| Female | 3 |
| Male | 8 |
| Hepatitis C Virus (HCV) Genotype/ Subtype(participants) | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| 1A | 8 |
| 1B | 3 |
| Interleukin 28B (IL28B) Genotype(participants) | ABT-450/r and ABT-072, Plus Ribavirin (RBV) |
|---|---|
| CC | 11 |
| CT | 0 |
| TT | 0 |
| Missing | 0 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Paritaprevir · ABT-072 · Ribavirin · Ritonavir
AbbVie (prior sponsor, Abbott) →