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CompletedNCT01715415Updated Aug 2, 2021Results posted

A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

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 2021-08-02.

Sponsored by AbbVie (prior sponsor, Abbott) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
395
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

02

Conditions studied

  • Chronic Hepatitis C Infection

Keywords

  • Hepatitis C
  • Treatment-Experienced
  • Null responder
  • Partial Responder
  • Chronic Hepatitis
  • Hepatitis C Genotype 1
  • Interferon-Free
  • Hepatitis C Virus
  • Relapser
  • Non responder
  • Viekira Pak
  • ombitasvir
  • ribavirin
  • ritonavir
  • paritaprevir
  • dasabuvir
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 395 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control.
  • Chronic hepatitis C, genotype 1 infection and HCV RNA level greater than 10,000 IU/mL at screening.
  • Previous treatment failure of peg-interferon and ribavirin (pegIFN and RBV).
  • No evidence of liver cirrhosis.

Exclusion criteria

Exclusion Criteria:

  • Positive screen for drugs or alcohol.
  • Significant sensitivity to any drug.
  • Use of contraindicated medications within 2 weeks of dosing.
  • Certain predefined abnormal laboratory tests.
  • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
395 participants (actual)

Study arms

  • Experimental
    ABT-450/r/ABT-267 and ABT-333, plus RBV

    Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (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

  • Experimental
    Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV

    Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (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 · Drug: Placebo for ABT-450/r/ABT-267 · Drug: Placebo for ABT-333 · Drug: Placebo for ribavirin

Interventions

  • DrugABT-450/r/ABT-267, ABT-333

    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

  • DrugRibavirin

    Capsule (double-blind treatment period), tablet (open-label treatment period)

  • DrugPlacebo for ABT-450/r/ABT-267

    Tablet

  • DrugPlacebo for ABT-333

    Tablet

  • DrugPlacebo for ribavirin

    Capsule

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After 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 active study drug

Secondary outcomes

  1. Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period

    Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.

    Time frame: At 12 weeks

  2. Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After 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 active study drug

  3. Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After 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 active study drug

  4. Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

    Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid \[HCV RNA\] ≥ lower limit of quantification \[LLOQ\] after HCV RNA \< LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.

    Time frame: 12 weeks after the last actual dose of active study drug

  5. Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

    Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the 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 post-treatment

07

Results

Posted Jan 6, 2015

Participant flow

Double-blind Treatment
Participant flow — Double-blind Treatment
MilestoneABT-450/r/ABT-267 and ABT-333, Plus RBVPlacebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV
Started29798
Randomized but not treated01
Completed29296
Not completed52
Withdrew: Did not receive study drug01
Withdrew: Adverse event30
Withdrew: Withdrawal by subject11
Withdrew: Other10
Open-label Treatment
Participant flow — Open-label Treatment
MilestoneABT-450/r/ABT-267 and ABT-333, Plus RBVPlacebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV
Started096
Completed094
Not completed02
Withdrew: Adverse event01
Withdrew: Subject noncompliant01

Outcome measures

PrimaryPercentage of Participants With Sustained Virologic Response 12 Weeks After 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 active study drug
Reported as:
Number · percentage of participants
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
percentage of participantsABT-450/r/ABT-267 and ABT-333, Plus RBV
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment96.3
Statistical analysis
  • ABT-450/r/ABT-267 and ABT-333, Plus RBV · Percentage of participants with svr12: 96.3 · 95% CI 94.1 to 98.495% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.
SecondaryPercentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period

Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.

Time frame:
At 12 weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
percentage of participantsABT-450/r/ABT-267 and ABT-333, Plus RBVPlacebo
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period96.912.8
Statistical analysis
  • ABT-450/r/ABT-267 and ABT-333, Plus RBV vs Placebo · Fisher Exact · p = <0.001 (In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.)
SecondaryPercentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After 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 active study drug
Reported as:
Number · percentage of participants
Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
percentage of participantsABT-450/r/ABT-267 and ABT-333, Plus RBV
Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment96.0
Statistical analysis
  • ABT-450/r/ABT-267 and ABT-333, Plus RBV · Percentage of participants with svr12: 96.0 · 95% CI 93.0 to 98.995% CI calculated using the normal approximation to the binomial distribution.
SecondaryPercentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After 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 active study drug
Reported as:
Number · percentage of participants
Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
percentage of participantsABT-450/r/ABT-267 and ABT-333, Plus RBV
Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment96.7
Statistical analysis
  • ABT-450/r/ABT-267 and ABT-333, Plus RBV · Percentage of participants with svr12: 96.7 · 95% CI 93.6 to 99.9
SecondaryPercentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid \[HCV RNA\] ≥ lower limit of quantification \[LLOQ\] after HCV RNA \< LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.

Time frame:
12 weeks after the last actual dose of active study drug
Reported as:
Number · percentage of participants
Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
percentage of participantsABT-450/r/ABT-267 and ABT-333, Plus RBV
Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm0 (0.0 to 0.0)
SecondaryPercentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the 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 post-treatment
Reported as:
Number · percentage of participants
Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
percentage of participantsABT-450/r/ABT-267 and ABT-333, Plus RBV
Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm2.4 (0.6 to 4.1)

Adverse events

Collected over Adverse events (AEs) were collected from the start of active study drug administration (double-blind [DB] or open-label [OL] active) to 30 days after the last dose of active study drug (total 16 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV—6/297 (2%)254/297 (85.5%)
Double Blind Placebo—1/97 (1%)74/97 (76.3%)
Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV—3/96 (3.1%)74/96 (77.1%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventDouble Blind ABT-450/r/ABT-267 and ABT-333, Plus RBVDouble Blind PlaceboOpen Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
BILE DUCT STONEHepatobiliary disorders0/2970/971/96
CALCULUS URETERICRenal and urinary disorders0/2970/971/96
ANGIOEDEMASkin and subcutaneous tissue disorders0/2970/971/96
ATRIAL FIBRILLATIONCardiac disorders0/2971/970/96
BRADYCARDIACardiac disorders1/2970/970/96
INTESTINAL OBSTRUCTIONGastrointestinal disorders1/2970/970/96
NAUSEAGastrointestinal disorders1/2970/970/96
VOMITINGGastrointestinal disorders1/2970/970/96
PNEUMONIAInfections and infestations1/2970/970/96
CEREBROVASCULAR ACCIDENTNervous system disorders1/2970/970/96
Most frequent other events
Showing 10 of 28
Most frequent other events
EventDouble Blind ABT-450/r/ABT-267 and ABT-333, Plus RBVDouble Blind PlaceboOpen Label ABT-450/r/ABT-267 and ABT-333, Plus RBV
HEADACHENervous system disorders108/29734/9718/96
FATIGUEGeneral disorders99/29722/9716/96
NAUSEAGastrointestinal disorders59/29717/9713/96
ASTHENIAGeneral disorders47/29711/9713/96
INSOMNIAPsychiatric disorders42/2977/9710/96
PRURITUSSkin and subcutaneous tissue disorders41/2975/9712/96
DYSPNOEARespiratory, thoracic and mediastinal disorders37/29710/9713/96
DIARRHOEAGastrointestinal disorders39/29712/978/96
COUGHRespiratory, thoracic and mediastinal disorders32/2975/9711/96
MYALGIAMusculoskeletal and connective tissue disorders23/29710/975/96

Baseline characteristics

Safety population: all randomized participants who received at least 1 dose of blinded study drug.

Age, Continuous
Age, Continuous(years)ABT-450/r/ABT-267 and ABT-333, Plus RBVPlaceboTotal
Mean51.7 ± 10.2654.9 ± 8.4652.5 ± 9.93
Sex: Female, Male
Sex: Female, Male(Participants)ABT-450/r/ABT-267 and ABT-333, Plus RBVPlaceboTotal
Female13037167
Male16760227
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1604-14. doi: 10.1056/NEJMoa1401561. Epub 2014 Apr 10. PubMed 24720679 ↗
  • Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14. PubMed 29377566 ↗

Related links

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01715415
Lead sponsor
AbbVie (prior sponsor, Abbott)
Responsible party
Sponsor
First posted
Oct 29, 2012
Start date
Nov 2012
Primary completion
Nov 2013
Completion
Oct 2014
Results posted
Jan 6, 2015
Last update
Aug 2, 2021

Study contacts

Jeff Enejosa, MD
study director · AbbVie

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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