NCT02582632

Brief Summary

This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 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

October 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

November 24, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 13, 2017

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

October 20, 2015

Results QC Date

November 16, 2017

Last Update Submit

July 28, 2021

Conditions

Hepatitis C InfectionHepatitis C Virus

Keywords

Hepatitis C VirusInterferon-FreeRibavirin-FreeHepatitis CHepatitis C Genotype 1b

Outcome Measures

Primary Outcomes (1)

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

    SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.

    12 weeks after the last actual dose of study drug

Secondary Outcomes (4)

  • Percentage of Participants With On-Treatment Virologic Failure During Treatment Period

    Up to 8 weeks while on treatment

  • Percentage of Participants With Post-Treatment Relapse12

    Up to 12 weeks after last dose of study drug

  • Percentage of Female Participants Responding With SVR12

    12 weeks after the last actual dose of study drug

  • Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12

    Baseline and 12 weeks after the last actual dose of study drug

Other Outcomes (5)

  • Percentage of Participants Who Achieve SVR12: mITT-GT Population

    12 weeks after the last actual dose of study drug

  • Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population

    Up to 8 weeks while on treatment

  • Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population

    Up to 12 weeks after last dose of study drug

  • +2 more other outcomes

Study Arms (1)

Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

EXPERIMENTAL

Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks

Drug: ombitasvir/paritaprevir/ritonavirDrug: dasabuvir

Interventions

ombitasvir/paritaprevir/ritonavirDRUG

Tablet

Also known as: ABT-267/ABT-450/r, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
dasabuvirDRUG

Tablet

Also known as: ABT-333
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic HCV infection at Screening.
  • Screening laboratory result indicating HCV genotype 1b infection.
  • Treatment-naïve and non-cirrhotic.

You may not qualify if:

  • HCV genotype or subtype other than GT1b.
  • Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
  • Any current or past clinical evidence of cirrhosis.
  • Screening laboratory analyses that shows abnormal results.
  • Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.

    PMID: 28416221BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

ombitasvirparitaprevirdasabuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • Emily Dumas, PhD

    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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 21, 2015

Study Start

November 24, 2015

Primary Completion

August 24, 2016

Study Completion

December 1, 2016

Last Updated

July 30, 2021

Results First Posted

December 13, 2017

Record last verified: 2021-07