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A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection (Quartz II/III)

Primary Purpose

Chronic Hepatitis C Virus Infection

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

OBV/PTV/r

Sofosbuvir

Ribavirin (RBV)

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus Infection focused on measuring Hepatitis C Virus, Genotype 2, Chronic Hepatitis C, Genotype 3, Non-cirrhotic, Cirrhotic

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

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)

Arm Description

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

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.

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.

Percentage of Participants With Post-treatment Relapse

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.

Full Information

NCT ID

NCT02292719

First Posted

November 13, 2014

Last Updated

July 8, 2021

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT02292719

Brief Title

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection

Acronym

Quartz II/III

Official Title

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 19, 2014 (Actual)

Primary Completion Date

July 14, 2017 (Actual)

Study Completion Date

July 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Virus Infection

Keywords

Hepatitis C Virus, Genotype 2, Chronic Hepatitis C, Genotype 3, Non-cirrhotic, Cirrhotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A (genotype [GT]3, noncirrhotic)

Arm Type

Experimental

Arm Description

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

Arm Title

Arm B (GT3, noncirrhotic)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm C (GT2, noncirrhotic)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm D (GT2, noncirrhotic)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm E (GT3, cirrhotic)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm F (GT3, noncirrhotic)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

OBV/PTV/r

Other Intervention Name(s)

ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir (r) also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE

Intervention Description

Tablet

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Other Intervention Name(s)

Sovaldi

Intervention Description

Tablet

Intervention Type

Drug

Intervention Name(s)

Ribavirin (RBV)

Intervention Description

Tablet

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

12 weeks after the last actual dose of study drug

Secondary Outcome Measure Information:

Title

Percentage of Participants With On-treatment Virologic Failure

Description

Time Frame

Up to Week 12

Title

Percentage of Participants With Post-treatment Relapse

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mariem Charafeddine, MD

Organizational Affiliation

AbbVie

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28833938

Citation

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.

Results Reference

background

PubMed Identifier

26596948

Citation

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.

Results Reference

derived

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection

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