AzTrials
AzTrials

Chronic Hepatitis C Virus InfectionPhase 2Quartz II/IIINCT02292719

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

A Phase 2 study testing OBV/PTV/r, Sofosbuvir and Ribavirin (RBV) in people with Chronic Hepatitis C Virus Infection, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Chronic Hepatitis C Virus Infection
What is being tested?
OBV/PTV/r, Sofosbuvir and Ribavirin (RBV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
19 Dec 2014to 14 Jul 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

About this study

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

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.

Being tested
OBV/PTV/r, Sofosbuvir, Ribavirin (RBV)
Keywords
Hepatitis C Virus, Genotype 2, Chronic Hepatitis C, Genotype 3, Non-cirrhotic, Cirrhotic
Medical subject headings
Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OBV/PTV/rDrug

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

    Tablet

  • SofosbuvirDrug

    Also called Sovaldi

    Tablet

  • Ribavirin (RBV)Drug

    Tablet

Study groups in NCT02292719
Study groupRoleWhat they receive
Arm A (genotype [GT]3, noncirrhotic)ExperimentalOmbitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Receives: Drug: OBV/PTV/r; Drug: Sofosbuvir
Arm B (GT3, noncirrhotic)ExperimentalOBV/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.
Receives: Drug: OBV/PTV/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Arm C (GT2, noncirrhotic)ExperimentalOBV/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.
Receives: Drug: OBV/PTV/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Arm D (GT2, noncirrhotic)ExperimentalOBV/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.
Receives: Drug: OBV/PTV/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Arm E (GT3, cirrhotic)ExperimentalOBV/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.
Receives: Drug: OBV/PTV/r; Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Arm F (GT3, noncirrhotic)ExperimentalOBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Receives: Drug: OBV/PTV/r; Drug: Sofosbuvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks after the last actual dose of study drug

Secondary outcomes (2)

  1. 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.

    Measured: Up to Week 12

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2014 (estimated)
  2. Study start19 Dec 2014
  3. Primary completion14 Jul 2017
  4. Study completion14 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02292719
Sponsor's protocol ID
M14-567
Other IDs
2014-003147-35, 2014
Acronym
Quartz II/III
Status last verified
Jul 2021
First submitted
13 Nov 2014
Last updated
12 Jul 2021
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28833938

  • 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.

    PubMed 26596948

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OBV/PTV/r, Sofosbuvir and Ribavirin (RBV) in people with Chronic Hepatitis C Virus Infection, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02292719, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in