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/NCT01609933
Registration number
NCT01609933
Ethics application status
Date submitted
30/05/2012
Date registered
1/06/2012
Date last updated
19/06/2018
Titles & IDs
Public title
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
Query!
Scientific title
An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon Alpha-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combination Study
Query!
Secondary ID [1]
0
0
M13-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
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 - ABT-450/r
Treatment: Drugs - ABT-267
Treatment: Drugs - pegylated interferon alpha-2a (pegIFN)
Treatment: Drugs - Ribavirin (RBV)
Experimental: 2-DAA + PegIFN/RBV - 2-direct-acting antiviral (2-DAA: ABT-450 [paritaprevir] 200 mg once daily [QD], ritonavir 100 mg QD, ABT-267 [ombitasvir] 25 mg QD) plus pegylated interferon alpha-2a (pegIFN) 180 mcg once weekly and Ribavirin (RBV) weight-based dosing, 1000 to 1200 mg divided twice daily (BID) for 24 weeks (Substudy 1) and followed by pegIFN and RBV alone for an additional 24 weeks (Substudy 2).
Treatment: Drugs: ABT-450/r
ABT-450 (tablets) dosed with ritonavir (capsules or tablets)
Treatment: Drugs: ABT-267
ABT-267 (tablets)
Treatment: Drugs: pegylated interferon alpha-2a (pegIFN)
pegIFN alpha-2a (syringe)
Treatment: Drugs: Ribavirin (RBV)
Ribavirin (tablets)
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 Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Query!
Assessment method [1]
0
0
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation [LLOQ] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Query!
Timepoint [1]
0
0
12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject's initial dose of study drug in Substudy 1
Query!
Secondary outcome [1]
0
0
Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)
Query!
Assessment method [1]
0
0
SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).
Query!
Timepoint [1]
0
0
24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject's initial dose of study drug in Substudy 1
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Query!
Assessment method [2]
0
0
eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ
Query!
Timepoint [2]
0
0
Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV)
Query!
Secondary outcome [3]
0
0
Number of Participants With Adverse Events
Query!
Assessment method [3]
0
0
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section.
Query!
Timepoint [3]
0
0
From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks).
Query!
Eligibility
Key inclusion criteria
Main Inclusion: To be enrolled in this protocol, subjects must meet all of the following
inclusion criteria:
- Subject must have experienced virologic failure as defined in a previous AbbVie/Abbott
direct-acting antiviral (DAA) combination trial.
- Female subjects of childbearing potential must be willing to use two effective forms
of birth control (not including oral contraceptives or contraceptives containing
ethinyl estradiol) while receiving study drug and for 7 months (or per local ribavirin
label) after stopping study drug.
- Males must be surgically sterile or have male partners only or agree to practice two
effective forms of birth control throughout the course of the study, starting with
Study Day 1 and for 7 months (or per local ribavirin label) after the last dose of
study drug, unless abstinent from sexual intercourse.
- Subject must be considered an appropriate candidate for peginterferon (pegIFN)
alpha-2a, ribavirin (RBV), ABT-450/ritonavir (r) and ABT-267 therapy in the opinion of
the investigator.
- Subject is infected with hepatitis C virus (HCV) genotype 1 at screening.
Subjects diagnosed with cirrhosis must also meet the following criteria:
- Compensated cirrhosis defined as Child-Pugh score of = 6 at Screening.
- Absence of hepatocellular carcinoma based on a negative ultrasound, computed
tomography (CT) scan or magnetic resonance imaging (MRI) performed within 3 months
prior to Screening or during the Screening period.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
71
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- In subjects with a prior null or partial response to pegIFN/RBV treatment at any time
prior to pre-screening for this study or any prior failure with pegIFN/RBV plus
telaprevir, the presence of variants relative to the appropriate prototypic reference
sequence (H77 for 1a or Con1 for 1b) at any of the following positions: NS3 155, 156,
or 168; or NS5A 28, 29, 30, 31, 32, 58, or 93.
- Females who are pregnant or plan to become pregnant, or breast-feeding, or males whose
partners are pregnant or planning to become pregnant within 7 months (or per local RBV
label) after their last dose of RBV.
- Use of known strong inducers (e.g., phenobarbital, rifampin, carbamazepine, St. John's
Wort) of Cytochrome P450 3A (CYP3A) within 2 weeks prior to study drug administration.
- Use of any medications contraindicated for use with pegIFN alpha-2a, RBV or ritonavir
within 2 weeks prior to study drug administration. Prior to entering the study,
subjects must be able to safely discontinue the contraindicated medication or switch
to an acceptable alternative under supervision of the investigator.
- Discontinuation of antiviral therapy due to intolerance or a DAA- or RBV-associated
adverse event in a previous AbbVie/Abbott DAA combination study.
Subjects with compensated cirrhosis must also not meet the following criteria:
- Any current or past clinical evidence of Child-Pugh B or C Classification or clinical
history of liver decompensation such as ascites (noted on physical exam), variceal
bleeding or hepatic encephalopathy.
- Serum Alpha-Fetoprotein (sAFP) > 100 ng/mL at Screening.
- A screening ultrasound suspicious for hepatocellular carcinoma and confirmed with a
subsequent CT scan or MRI during the screening period.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
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
Single group
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
18/12/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
3/05/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
32
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie (prior sponsor, Abbott)
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
did not respond to treatment in a previous AbbVie/Abbott combination study.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01609933
Query!
Trial related presentations / publications
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
AbbVie Inc.
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/NCT01609933
Download to PDF