NCT02292719

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2014

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

November 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 19, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 6, 2018

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

2.6 years

First QC Date

November 13, 2014

Results QC Date

June 7, 2018

Last Update Submit

July 8, 2021

Conditions

Chronic Hepatitis C Virus Infection

Keywords

Hepatitis C VirusGenotype 2Chronic Hepatitis CGenotype 3Non-cirrhoticCirrhotic

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks after the last actual dose of study drug

Secondary Outcomes (2)

  • Percentage of Participants With On-treatment Virologic Failure

    Up to Week 12

  • Percentage of Participants With Post-treatment Relapse

    Up to 12 weeks after the last actual dose of active study drug

Study Arms (6)

Arm A (genotype [GT]3, noncirrhotic)

EXPERIMENTAL

Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.

Drug: OBV/PTV/rDrug: Sofosbuvir

Arm B (GT3, noncirrhotic)

EXPERIMENTAL

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily \[BID\]) for 12 weeks.

Drug: OBV/PTV/rDrug: SofosbuvirDrug: Ribavirin (RBV)

Arm C (GT2, noncirrhotic)

EXPERIMENTAL

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.

Drug: OBV/PTV/rDrug: SofosbuvirDrug: Ribavirin (RBV)

Arm D (GT2, noncirrhotic)

EXPERIMENTAL

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.

Drug: OBV/PTV/rDrug: SofosbuvirDrug: Ribavirin (RBV)

Arm E (GT3, cirrhotic)

EXPERIMENTAL

OBV/PTV/r (25/150/100) mg QD with SOF (400 mg QD) and RBV (weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.

Drug: OBV/PTV/rDrug: SofosbuvirDrug: Ribavirin (RBV)

Arm F (GT3, noncirrhotic)

EXPERIMENTAL

OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.

Drug: OBV/PTV/rDrug: Sofosbuvir

Interventions

OBV/PTV/rDRUG

Tablet

Also known as: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir (r) also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
Arm A (genotype [GT]3, noncirrhotic)Arm B (GT3, noncirrhotic)Arm C (GT2, noncirrhotic)Arm D (GT2, noncirrhotic)Arm E (GT3, cirrhotic)Arm F (GT3, noncirrhotic)
SofosbuvirDRUG

Tablet

Also known as: Sovaldi
Arm A (genotype [GT]3, noncirrhotic)Arm B (GT3, noncirrhotic)Arm C (GT2, noncirrhotic)Arm D (GT2, noncirrhotic)Arm E (GT3, cirrhotic)Arm F (GT3, noncirrhotic)
Ribavirin (RBV)DRUG

Tablet

Arm B (GT3, noncirrhotic)Arm C (GT2, noncirrhotic)Arm D (GT2, noncirrhotic)Arm E (GT3, cirrhotic)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic HCV infection prior to study enrollment.
  • Screening laboratory results from the central clinical laboratory indicating HCV genotype 2 or 3 infection only (no mixed genotype).
  • Absence OR presence of cirrhosis.
  • If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular carcinoma (HCC)

You may not qualify if:

  • Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus antibody
  • Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse.
  • Current enrollment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV therapy (other than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir, boceprevir, ABT-450, or ombitasvir (ABT-267).
  • Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
  • Abnormal lab tests.
  • Females who are pregnant or plan to become pregnant or breastfeeding, or males whose partners are pregnant or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Shafran SD, Shaw D, Charafeddine M, Agarwal K, Foster GR, Abunimeh M, Pilot-Matias T, Pothacamury RK, Fu B, Cohen E, Cohen DE, Gane E. Efficacy and safety results of patients with HCV genotype 2 or 3 infection treated with ombitasvir/paritaprevir/ritonavir and sofosbuvir with or without ribavirin (QUARTZ II-III). J Viral Hepat. 2018 Feb;25(2):118-125. doi: 10.1111/jvh.12782. Epub 2017 Sep 14.

    PMID: 28833938BACKGROUND

  • King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother. 2015 Nov 23;60(2):855-61. doi: 10.1128/AAC.01913-15. Print 2016 Feb.

    PMID: 26596948DERIVED

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

ombitasvirparitaprevirRitonavirSofosbuvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsUridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
abbvieclinicaltrials@abbvie.com
800-633-9110

Study Officials

  • Mariem Charafeddine, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 17, 2014

Study Start

December 19, 2014

Primary Completion

July 14, 2017

Study Completion

July 14, 2017

Last Updated

July 12, 2021

Results First Posted

July 6, 2018

Record last verified: 2021-07