Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02292719
Registration number
NCT02292719
Ethics application status
Date submitted
13/11/2014
Date registered
17/11/2014
Date last updated
12/07/2021
Titles & IDs
Public 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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2014-003147-35
Query!
Secondary ID [2]
0
0
M14-567
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Quartz II/III
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Virus Infection
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Sexually transmitted infections
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - OBV/PTV/r
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - Ribavirin (RBV)
Experimental: Arm A (genotype [GT]3, noncirrhotic) - Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
Experimental: Arm B (GT3, noncirrhotic) - 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.
Experimental: Arm C (GT2, noncirrhotic) - 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.
Experimental: Arm D (GT2, noncirrhotic) - 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.
Experimental: Arm E (GT3, cirrhotic) - 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.
Experimental: Arm F (GT3, noncirrhotic) - OBV/PTV/r (25/150/100) mg QD and SOF (400 mg QD) for 12 weeks.
Treatment: Drugs: OBV/PTV/r
Tablet
Treatment: Drugs: Sofosbuvir
Tablet
Treatment: Drugs: Ribavirin (RBV)
Tablet
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 weeks after the last actual dose of study drug
Query!
Secondary outcome [1]
0
0
Percentage of Participants With On-treatment Virologic Failure
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to Week 12
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Post-treatment Relapse
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to 12 weeks after the last actual dose of active study drug
Query!
Eligibility
Key inclusion criteria
1. Chronic HCV infection prior to study enrollment.
2. Screening laboratory results from the central clinical laboratory indicating HCV
genotype 2 or 3 infection only (no mixed genotype).
3. Absence OR presence of cirrhosis.
4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular
carcinoma (HCC)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
99
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
antibody
2. Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse.
3. 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).
4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.
5. Abnormal lab tests.
6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose
partners are pregnant or planning to become pregnant
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/12/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
14/07/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
70
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02292719
Query!
Trial related presentations / 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.
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Mariem Charafeddine, MD
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02292719
Download to PDF