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Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

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ClinicalTrials.gov Identifier: NCT02493855
Recruitment Status : Completed
First Posted : July 10, 2015
Results First Posted : May 15, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE July 2, 2015
First Posted Date  ICMJE July 10, 2015
Results First Submitted Date  ICMJE April 6, 2017
Results First Posted Date  ICMJE May 15, 2017
Last Update Posted Date October 31, 2017
Actual Study Start Date  ICMJE June 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment [ Time Frame: From Week 0 to Week 2 ]
HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Slope of the second phase decline in plasma HCV RNA levels during treatment [ Time Frame: From Week 0 to Week 2 ]
The effect of RBV on second phase plasma HCV ribonucleic acid (RNA) decline in subjects who receive the 3-direct-acting antiviral agent (DAA) regimen of ombitasvir/ABT-450/r and dasabuvir with full dose RBV compared to the 3-DAA regimen with low dose RBV or without RBV in treatment-naive HCV genotype (GT) 1a-infected adult subjects.
Change History Complete list of historical versions of study NCT02493855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
Official Title  ICMJE An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection
Brief Summary To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C
  • Hepatitis C (HCV)
  • Hepatitis C Genotype 1a
Intervention  ICMJE
  • Drug: Ombitasvir/ABT-450/Ritonavir
    Ombitasvir/ABT-450/ritonavir combination tablets
    Other Name: ABT-267/ABT-450/ritonavir
  • Drug: Dasabuvir
    Dasabuvir tablets
    Other Name: ABT-333
  • Drug: Ribavirin (RBV)
    Ribavirin tablets
Study Arms  ICMJE
  • Experimental: Arm A: Ribavirin Full Dose for Last 10 Weeks
    Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
    Interventions:
    • Drug: Ombitasvir/ABT-450/Ritonavir
    • Drug: Dasabuvir
    • Drug: Ribavirin (RBV)
  • Experimental: Arm B: Ribavirin Full Dose for 12 Weeks
    Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
    Interventions:
    • Drug: Ombitasvir/ABT-450/Ritonavir
    • Drug: Dasabuvir
    • Drug: Ribavirin (RBV)
  • Experimental: Arm C: Ribavirin Low-dose for 12 Weeks
    Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
    Interventions:
    • Drug: Ombitasvir/ABT-450/Ritonavir
    • Drug: Dasabuvir
    • Drug: Ribavirin (RBV)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
46
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
60
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
  2. Chronic HCV infection.
  3. Subjects must be non-cirrhotic.
  4. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.

Exclusion Criteria:

  1. Women who are pregnant or breastfeeding.
  2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
  3. Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
  4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
  5. History or solid organ transplant.
  6. Screening laboratory analysis that shows abnormal results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries France,   United States
 
Administrative Information
NCT Number  ICMJE NCT02493855
Other Study ID Numbers  ICMJE M14-242
2014-001478-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emily Dumas, PhD AbbVie
PRS Account AbbVie
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP