Clinical Trials

MainTitle

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02487199

First received: June 29, 2015
Last updated: October 31, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

Condition Intervention Phase
Hepatitis C Virus (HCV)

Drug : ombitasvir/paritaprevir/ritonavir and dasabuvir
Drug : ombitasvir/paritaprevir/ritonavir
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (
  • Number of Participants With Adverse Events [ Time Frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks) ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.
Secondary Outcome Measures:
  • Percentage of Participants With On-treatment Virologic Failure [ Time Frame: 12 weeks ]
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment.
  • Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

Enrollment: 18
Study Start Date: September 30, 2015
Study Completion Date: December 5, 2016
Primary Completion Date: December 5, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: HCV GT1a (3-DAA)
Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks.
Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Other Name: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
Experimental: HCV GT4 (2-DAA)
Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks.
Drug: ombitasvir/paritaprevir/ritonavir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Other Name: Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).
  • Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
  • Chronic kidney disease stage 4 or stage 5.


Exclusion Criteria:
  • Females who are pregnant or breastfeeding
  • Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
  • HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
  • Abnormal laboratory tests
  • Current enrollment in another investigational study
  • Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
  • Current treatment with a direct acting antiviral agent (DAA) containing regimen
  • Any evidence of liver cirrhosis or liver cancer

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02487199

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc AbbVie
More Information

More Information

Additional Information:

Related Info

Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02487199   History of Changes  
Other Study ID Numbers: M15-461  
  2015-002012-33  
Study First Received: June 29, 2015  
Last Updated: October 31, 2017  

Keywords provided by AbbVie:

hepatitis C infection
hepatitis C
severe kidney disease
chronic kidney disease
Genotype 1a
Genotype 4
treatment experienced
interferon
IFN
pegIFN

Additional relevant MeSH terms:
Infection
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Kidney Diseases
Ritonavir

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.