We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02966795




Registration number
NCT02966795
Ethics application status
Date submitted
15/11/2016
Date registered
17/11/2016
Date last updated
10/07/2019

Titles & IDs
Public title
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Scientific title
A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Secondary ID [1] 0 0
2016-003192-22
Secondary ID [2] 0 0
M16-126
Universal Trial Number (UTN)
Trial acronym
ENDURANCE-5 6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus (HCV) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Glecaprevir/Pibrentasvir

Experimental: Glecaprevir/Pibrentasvir for 8 Weeks - Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.

Experimental: Glecaprevir/Pibrentasvir for 12 Weeks - Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label.


Treatment: Drugs: Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) - SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
Timepoint [1] 0 0
12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Secondary outcome [1] 0 0
Percentage of Participants With On-treatment HCV Virologic Failure - HCV virologic failure was defined as one of the following conditions:
confirmed HCV RNA = 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or
HCV RNA = 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration = 36 days.
Timepoint [1] 0 0
8 or 12 weeks (depending on the treatment regimen)
Secondary outcome [2] 0 0
Percentage of Participants With Relapse - Relapse was defined as confirmed HCV RNA = 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
Timepoint [2] 0 0
End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.

Eligibility
Key inclusion criteria
- Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.

- Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid
(RNA) greater than or equal to 1000 IU/mL at Screening Visit.

- Participant must be HCV treatment-naïve (i.e., has never received a single dose of any
approved or investigational anti-HCV medication) or treatment-experienced (i.e., has
failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without
ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior
HCV treatment with any other approved or investigational medications is not allowed.
Previous HCV treatment must have been completed greater than or equal to 2 months
prior to screening.

- Participant must be documented as having no cirrhosis or compensated cirrhosis.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Female participant who is pregnant, breastfeeding, or is considering becoming pregnant
during the study or for approximately 30 days after the last dose of study drug.

- Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse that could preclude adherence to the protocol in the opinion of the
investigator.

- Positive test result at screening for hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab).

- HCV genotype performed during screening indicating co-infection with more than one HCV
genotype.

- History of severe, life-threatening or other significant sensitivity to any excipients
of the study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Nepean Hospital Kingswood /ID# 157027 - Kingswood
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital /ID# 157025 - Herston
Recruitment hospital [3] 0 0
Royal Melbourne Hospital /ID# 157024 - Parkville
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Washington
Country [4] 0 0
Belgium
State/province [4] 0 0
Kortrijk
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
France
State/province [8] 0 0
Gironde
Country [9] 0 0
France
State/province [9] 0 0
Ile-de-France
Country [10] 0 0
France
State/province [10] 0 0
Clermont Ferrand
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
Singapore
State/province [13] 0 0
Singapore
Country [14] 0 0
South Africa
State/province [14] 0 0
Gauteng
Country [15] 0 0
South Africa
State/province [15] 0 0
Western Cape
Country [16] 0 0
Vietnam
State/province [16] 0 0
Hanoi
Country [17] 0 0
Vietnam
State/province [17] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of
glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic
hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis
respectively.
Trial website
https://clinicaltrials.gov/show/NCT02966795
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications