NCT02487199

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 4, 2017

Completed
Last Updated

December 4, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

June 29, 2015

Results QC Date

October 31, 2017

Last Update Submit

October 31, 2017

Conditions

Hepatitis C Virus (HCV)

Keywords

hepatitis C infectionhepatitis Csevere kidney diseasechronic kidney diseaseGenotype 1aGenotype 4treatment experiencedinterferonIFNpegIFN

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.

    12 weeks after the last actual dose of study drug

  • Number of Participants With Adverse Events

    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.

    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)

Secondary Outcomes (2)

  • Percentage of Participants With On-treatment Virologic Failure

    12 weeks

  • Percentage of Participants With Post-treatment Relapse

    From the end of treatment through 12 weeks after the last dose of study drug

Study Arms (2)

HCV GT1a (3-DAA)

EXPERIMENTAL

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

HCV GT4 (2-DAA)

EXPERIMENTAL

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

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvirDRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Also known as: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
HCV GT1a (3-DAA)
ombitasvir/paritaprevir/ritonavirDRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Also known as: Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267
HCV GT4 (2-DAA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5.

    PMID: 30291369DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis CKidney DiseasesRenal Insufficiency, Chronic

Interventions

ombitasvirdasabuvirViekira Pakparitaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • AbbVie Inc

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 1, 2015

Study Start

September 30, 2015

Primary Completion

December 5, 2016

Study Completion

December 5, 2016

Last Updated

December 4, 2017

Results First Posted

December 4, 2017

Record last verified: 2017-10