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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01464827




Registration number
NCT01464827
Ethics application status
Date submitted
28/09/2011
Date registered
4/11/2011
Date last updated
22/04/2015

Titles & IDs
Public title
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Scientific title
A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Secondary ID [1] 0 0
2010-022455-31
Secondary ID [2] 0 0
M11-652
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Hepatitis C (HCV) 0 0
Hepatitis C Genotype 1 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
Description of intervention(s) / exposure
Treatment: Drugs - ABT-450
Treatment: Drugs - ABT-333
Treatment: Drugs - ABT-267
Treatment: Drugs - Ribavirin
Treatment: Drugs - Ritonavir

Experimental: Group A - Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.

Experimental: Group B - Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Experimental: Group C - Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Experimental: Group D - Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Experimental: Group E - Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.

Experimental: Group F - Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.

Experimental: Group G - Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Experimental: Group H - Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Experimental: Group I - Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Experimental: Group J - Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Experimental: Group K - Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Experimental: Group L - Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.

Experimental: Group M - Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.

Experimental: Group N - Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.


Treatment: Drugs: ABT-450
ABT-450 tablets

Treatment: Drugs: ABT-333
ABT-333 tablets

Treatment: Drugs: ABT-267
ABT-267 tablets

Treatment: Drugs: Ribavirin
Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).
Primary outcome [2] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin
Timepoint [2] 0 0
Post Treatment Week 24
Secondary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin
Timepoint [1] 0 0
Post-Treatment Week 24
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin
Timepoint [2] 0 0
Post-Treatment Week 24
Secondary outcome [3] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin
Timepoint [3] 0 0
Post-Treatment Week 24
Secondary outcome [4] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders
Timepoint [4] 0 0
Post-Treatment Week 24

Eligibility
Key inclusion criteria
- Males and females 18-70 years old, inclusive

- Females must be post-menopausal for more than 2 years or surgically sterile or
practicing specific forms of birth control

- Chronic hepatitis C virus (HCV), genotype 1 infection

- Treatment-naive OR null-responders to previous treatment with pegylated interferon
(pegIFN) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2
log10 HCV RNA decrease at Week 12)

- No evidence of liver cirrhosis
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant liver disease with any cause other than HCV as the primary cause

- Positive hepatitis B surface antigen and anti-human immunodeficiency virus antibody

- Positive screen for drugs and alcohol

- Significant sensitivity to any drug

- Use of contraindicated or prohibited medications within 1 month of dosing

- Abnormal laboratory tests

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
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
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
580
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 44850 - Adelaide
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 44849 - Herston
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 44852 - Kogarah
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Canada
State/province [28] 0 0
Calgary
Country [29] 0 0
Canada
State/province [29] 0 0
Vancouver
Country [30] 0 0
France
State/province [30] 0 0
Clichy
Country [31] 0 0
France
State/province [31] 0 0
Creteil
Country [32] 0 0
France
State/province [32] 0 0
Lyon
Country [33] 0 0
France
State/province [33] 0 0
Marseilles
Country [34] 0 0
France
State/province [34] 0 0
Montpellier - Cedex 5
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Pessac
Country [37] 0 0
France
State/province [37] 0 0
Vandoeuvre Les Nancy
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Frankfurt
Country [40] 0 0
Germany
State/province [40] 0 0
Hamburg
Country [41] 0 0
Germany
State/province [41] 0 0
Hannover
Country [42] 0 0
Germany
State/province [42] 0 0
Kiel
Country [43] 0 0
Germany
State/province [43] 0 0
Wuerzburg
Country [44] 0 0
New Zealand
State/province [44] 0 0
Auckland
Country [45] 0 0
Puerto Rico
State/province [45] 0 0
San Juan
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Majadahonda (Madrid)
Country [49] 0 0
Spain
State/province [49] 0 0
Seville
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Dundee
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Nottingham
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin
(RBV) in patients with chronic Hepatitis C Virus (HCV).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01464827
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Cohen, MD
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT01464827