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/NCT00192647
Registration number
NCT00192647
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
4/08/2016
Titles & IDs
Public title
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
Query!
Scientific title
A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1
Query!
Secondary ID [1]
0
0
ML17908
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic
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 - PEG-IFN alfa-2a
Treatment: Drugs - Ribavirin
Experimental: PEG-IFN alfa-2a+Ribavirin - Induction Treatment - Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
Experimental: PEG-IFN alfa-2a+Ribavirin - Standard Treatment - Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
Treatment: Drugs: PEG-IFN alfa-2a
PEG-IFN alfa-2a will be administered once weekly for 48 weeks, at doses specified in respective arms.
Treatment: Drugs: Ribavirin
Ribavirin 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight, for 48 weeks.
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 Virological Response According to Scheduled Treatment Period
Query!
Assessment method [1]
0
0
Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.
Query!
Timepoint [1]
0
0
Week 72
Query!
Secondary outcome [1]
0
0
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period
Query!
Assessment method [1]
0
0
Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.
Query!
Timepoint [1]
0
0
Weeks 48
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Virological Responses Over Time
Query!
Assessment method [2]
0
0
Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.
Query!
Timepoint [2]
0
0
Weeks 4, 8, 12, and 24
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Relapse of End-of-treatment Virological Response
Query!
Assessment method [3]
0
0
Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.
Query!
Timepoint [3]
0
0
Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response
Query!
Assessment method [4]
0
0
The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.
Query!
Timepoint [4]
0
0
Weeks 4, 12, and 72
Query!
Secondary outcome [5]
0
0
Change From Baseline in Log10 HCV RNA Values
Query!
Assessment method [5]
0
0
The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.
Query!
Timepoint [5]
0
0
Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)
Query!
Eligibility
Key inclusion criteria
- Diagnosis of chronic CHC, genotype 1
- Chronic liver disease consistent with CHC on a biopsy sample obtained within the
previous 36 months as judged by a local pathologist (all countries except Australia)
- Infection with Hepatitis C virus (Australian sites only had to meet Section 100
criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
- Compensated liver disease
- Naive to interferon-based therapy for CHC infection
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of
study drug
- Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus
(HIV)
- Chronic liver disease other than CHC infection
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised 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 4
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
1/08/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
896
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Bankstown
Query!
Recruitment hospital [3]
0
0
- Box Hill
Query!
Recruitment hospital [4]
0
0
- Brisbane
Query!
Recruitment hospital [5]
0
0
- Cottontree
Query!
Recruitment hospital [6]
0
0
- Darlinghurst
Query!
Recruitment hospital [7]
0
0
- Douglas
Query!
Recruitment hospital [8]
0
0
- Fitzroy
Query!
Recruitment hospital [9]
0
0
- Fremantle
Query!
Recruitment hospital [10]
0
0
- Geelong
Query!
Recruitment hospital [11]
0
0
- Greenslopes
Query!
Recruitment hospital [12]
0
0
- Kingswood
Query!
Recruitment hospital [13]
0
0
- Lismore
Query!
Recruitment hospital [14]
0
0
- Liverpool
Query!
Recruitment hospital [15]
0
0
- Melbourne
Query!
Recruitment hospital [16]
0
0
- Miranda
Query!
Recruitment hospital [17]
0
0
- Nedlands
Query!
Recruitment hospital [18]
0
0
- New Lambton Heights
Query!
Recruitment hospital [19]
0
0
- Parkville
Query!
Recruitment hospital [20]
0
0
- Perth
Query!
Recruitment hospital [21]
0
0
- Sydney
Query!
Recruitment hospital [22]
0
0
- Victoria
Query!
Recruitment hospital [23]
0
0
- Woden
Query!
Recruitment hospital [24]
0
0
- Wollongong
Query!
Recruitment hospital [25]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
5042 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
2200 - Bankstown
Query!
Recruitment postcode(s) [4]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [5]
0
0
4029 - Brisbane
Query!
Recruitment postcode(s) [6]
0
0
4558 - Cottontree
Query!
Recruitment postcode(s) [7]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [8]
0
0
- Douglas
Query!
Recruitment postcode(s) [9]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [10]
0
0
6160 - Fremantle
Query!
Recruitment postcode(s) [11]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [12]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [13]
0
0
- Kingswood
Query!
Recruitment postcode(s) [14]
0
0
2480 - Lismore
Query!
Recruitment postcode(s) [15]
0
0
1871 - Liverpool
Query!
Recruitment postcode(s) [16]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [17]
0
0
3011 - Melbourne
Query!
Recruitment postcode(s) [18]
0
0
3084 - Melbourne
Query!
Recruitment postcode(s) [19]
0
0
3181 - Melbourne
Query!
Recruitment postcode(s) [20]
0
0
3186 - Melbourne
Query!
Recruitment postcode(s) [21]
0
0
2228 - Miranda
Query!
Recruitment postcode(s) [22]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [23]
0
0
2310 - New Lambton Heights
Query!
Recruitment postcode(s) [24]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [25]
0
0
6001 - Perth
Query!
Recruitment postcode(s) [26]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [27]
0
0
2050 - Sydney
Query!
Recruitment postcode(s) [28]
0
0
2139 - Sydney
Query!
Recruitment postcode(s) [29]
0
0
2145 - Sydney
Query!
Recruitment postcode(s) [30]
0
0
3199 - Victoria
Query!
Recruitment postcode(s) [31]
0
0
2606 - Woden
Query!
Recruitment postcode(s) [32]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [33]
0
0
4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
La Plata
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Rosario
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
Alberta
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
British Columbia
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Quebec
Query!
Country [8]
0
0
Mexico
Query!
State/province [8]
0
0
Guadalajara
Query!
Country [9]
0
0
Mexico
Query!
State/province [9]
0
0
Monterrey
Query!
Country [10]
0
0
New Zealand
Query!
State/province [10]
0
0
Auckland
Query!
Country [11]
0
0
New Zealand
Query!
State/province [11]
0
0
Hamilton
Query!
Country [12]
0
0
New Zealand
Query!
State/province [12]
0
0
Riccarton, Christchurch
Query!
Country [13]
0
0
Thailand
Query!
State/province [13]
0
0
Bangkok
Query!
Country [14]
0
0
Thailand
Query!
State/province [14]
0
0
Chiang Mai
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate the addition of a higher-dose induction treatment period with
peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with
PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive
participants with CHC, genotype 1 infection.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00192647
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
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/NCT00192647
Download to PDF