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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02441283




Registration number
NCT02441283
Ethics application status
Date submitted
29/04/2015
Date registered
12/05/2015
Date last updated
21/09/2020

Titles & IDs
Public title
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
Scientific title
A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Secondary ID [1] 0 0
2015-000452-24
Secondary ID [2] 0 0
M13-576
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 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 - ABT-493
Treatment: Drugs - ABT-530

No Intervention: HCV-infected Participants - Hepatitis C virus (HCV)-infected participants who received ABT-493 and/or ABT-530 in prior Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV and were not retreated prior to entering this study. No AbbVie study drug was administered in this study.


Treatment: Drugs: ABT-493
ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

Treatment: Drugs: ABT-530
ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen - Maintaining a sustained virologic response (SVR) is defined as having Hepatitis C virus ribonucleic acid (HCV RNA) value consistently below the lower limit of quantification (< LLOQ) from the end of treatment in the previous study throughout Study M13-576 (this study).
Timepoint [1] 0 0
From the end of treatment in the previous study up to 3 years post-treatment
Primary outcome [2] 0 0
Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen - Relapse was defined as confirmed Hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (= LLOQ) between end of treatment and up to and including the last HCV RNA measurement collected in this study for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment, excluding reinfection. HCV reinfection was defined as confirmed HCV RNA = LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at Final Treatment Visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences.
Timepoint [2] 0 0
From the end of treatment in the previous study up to 3 years post-treatment
Primary outcome [3] 0 0
Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure - Plasma samples for HCV resistance testing were collected at study visits. The variants in nonstructural viral protein 3 (NS3) and nonstructural viral protein 5A (NS5A) at amino acid positions of interest were analyzed by next generation sequencing relative to baseline and prototypic reference sequences.
Timepoint [3] 0 0
From Day 1 to Month 12
Secondary outcome [1] 0 0
Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection - Any events (i.e., diagnoses) related to liver disease progression and/or HCV infection considered to be clinically significant by the investigator that began or worsened after Day 1 were documented until the end of the study or initiation of re-treatment for HCV (if applicable). Significant events related to liver disease progression include the development of cirrhosis, events indicative of hepatic decompensation, (including: variceal bleeding, new ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepato-renal syndrome, hepatic hydrothorax or other evidence of hepatic decompensation considered to be significant by the investigator), change in the Child-Pugh category (e.g., change from Child-Pugh Class A to Child-Pugh Class B), the occurrence of hepatocellular carcinoma, liver transplantation and/or death.
Timepoint [1] 0 0
After Day 1 up to 3 years post-treatment
Secondary outcome [2] 0 0
Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time - A plasma sample for IP-10 testing was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). IP-10 is used to assess liver fibrosis in participants with chronic liver disease.
Timepoint [2] 0 0
From Day 1 up to 3 years post-treatment
Secondary outcome [3] 0 0
Mean FibroTest Score Over Time - A serum sample for FibroTest evaluation was collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). FibroTest uses six biomarkers to generate a score that correlates to the degree of liver damage in participants. Scores range from 0 to 1, with higher scores indicating more severe liver fibrosis.
Timepoint [3] 0 0
From Day 1 up to 3 years post-treatment
Secondary outcome [4] 0 0
Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time - A serum sample for aspartate transaminase evaluation and platelets were collected at study visits for all participants, until the end of the study or initiation of re-treatment for HCV (if applicable). The aspartate transaminase to platelet ratio index (APRI) is used to assess liver fibrosis in participants with chronic liver disease. Scores range from 0 to = 2.0, with scores < 0.5 predictive of no liver fibrosis; scores >1.5 significant fibrosis; and scores > 2.0 indicative of cirrhosis.
Timepoint [4] 0 0
From Day 1 up to 3 years post-treatment
Secondary outcome [5] 0 0
Mean FibroScan Scores Over Time - The FibroScan test is used to assess liver fibrosis in participants with chronic liver disease. This was not performed as a study procedure, but any available results from source documents were summarized. For participants with Hepatitis C infection, a Fibroscan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis.
Timepoint [5] 0 0
Up to 3 years post-treatment

Eligibility
Key inclusion criteria
1. Participant is male or female 18 years of age or older

2. Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing
regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study

3. The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA)
therapy from the previous clinical study and enrollment in Study M13-576 must be no
longer than 2 years for subjects who have not been retreated. Participants who have
been treated with a commercially available anti-HCV treatment may be enrolled greater
than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical
study.

4. Participant must voluntarily sign and date the informed consent form approved by an
Independent Review Board or Ethics Committee prior to the initiation of any
study-specific procedures.

5. Participant completed the post-treatment period of an eligible prior study.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The investigator considers the participant unsuitable for the study for any reasons
(e.g., failure to comply with study procedures in the prior AbbVie clinical study).

2. Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or
ABT-530 in the prior study.

3. Participants who experienced non-virologic treatment failure due to premature
discontinuation of study drug in prior study of ABT-493/ABT-530.

4. Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic
failure in the prior Phase 2 or 3 study.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
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 2/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,SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital, Darlinghurst /ID# 155395 - Darlinghurst
Recruitment hospital [2] 0 0
St. Vincents Hospital /ID# 155394 - East Lismore
Recruitment hospital [3] 0 0
Westmead Hospital /ID# 155392 - Westmead
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital /ID# 155396 - Herston
Recruitment hospital [5] 0 0
Royal Adelaide Hospital /ID# 155391 - Adelaide
Recruitment hospital [6] 0 0
Royal Melbourne Hospital /ID# 155393 - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2480 - East Lismore
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles-Capitale
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Germany
State/province [17] 0 0
Hessen
Country [18] 0 0
Germany
State/province [18] 0 0
Dusseldorf
Country [19] 0 0
Germany
State/province [19] 0 0
Kiel
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
Puerto Rico
State/province [21] 0 0
Ponce
Country [22] 0 0
Puerto Rico
State/province [22] 0 0
San Juan
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London, City Of
Country [24] 0 0
United Kingdom
State/province [24] 0 0
London
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
This was a long-term follow-up study to evaluate the durability of sustained virologic
response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical
outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in
prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus
(HCV) infection.
Trial website
https://clinicaltrials.gov/show/NCT02441283
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