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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
ML17908
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 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 - 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.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period - 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.
Timepoint [1] 0 0
Week 72
Secondary outcome [1] 0 0
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period - 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.
Timepoint [1] 0 0
Weeks 48
Secondary outcome [2] 0 0
Percentage of Participants With Virological Responses Over Time - 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.
Timepoint [2] 0 0
Weeks 4, 8, 12, and 24
Secondary outcome [3] 0 0
Percentage of Participants With Relapse of End-of-treatment Virological Response - 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.
Timepoint [3] 0 0
Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)
Secondary outcome [4] 0 0
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response - 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.
Timepoint [4] 0 0
Weeks 4, 12, and 72
Secondary outcome [5] 0 0
Change From Baseline in Log10 HCV RNA Values - The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

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
Parallel
Other design features
Phase
Phase 4
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)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bankstown
Recruitment hospital [3] 0 0
- Box Hill
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
- Cottontree
Recruitment hospital [6] 0 0
- Darlinghurst
Recruitment hospital [7] 0 0
- Douglas
Recruitment hospital [8] 0 0
- Fitzroy
Recruitment hospital [9] 0 0
- Fremantle
Recruitment hospital [10] 0 0
- Geelong
Recruitment hospital [11] 0 0
- Greenslopes
Recruitment hospital [12] 0 0
- Kingswood
Recruitment hospital [13] 0 0
- Lismore
Recruitment hospital [14] 0 0
- Liverpool
Recruitment hospital [15] 0 0
- Melbourne
Recruitment hospital [16] 0 0
- Miranda
Recruitment hospital [17] 0 0
- Nedlands
Recruitment hospital [18] 0 0
- New Lambton Heights
Recruitment hospital [19] 0 0
- Parkville
Recruitment hospital [20] 0 0
- Perth
Recruitment hospital [21] 0 0
- Sydney
Recruitment hospital [22] 0 0
- Victoria
Recruitment hospital [23] 0 0
- Woden
Recruitment hospital [24] 0 0
- Wollongong
Recruitment hospital [25] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
2200 - Bankstown
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
4558 - Cottontree
Recruitment postcode(s) [7] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [8] 0 0
- Douglas
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
4120 - Greenslopes
Recruitment postcode(s) [13] 0 0
- Kingswood
Recruitment postcode(s) [14] 0 0
2480 - Lismore
Recruitment postcode(s) [15] 0 0
1871 - Liverpool
Recruitment postcode(s) [16] 0 0
2170 - Liverpool
Recruitment postcode(s) [17] 0 0
3011 - Melbourne
Recruitment postcode(s) [18] 0 0
3084 - Melbourne
Recruitment postcode(s) [19] 0 0
3181 - Melbourne
Recruitment postcode(s) [20] 0 0
3186 - Melbourne
Recruitment postcode(s) [21] 0 0
2228 - Miranda
Recruitment postcode(s) [22] 0 0
6009 - Nedlands
Recruitment postcode(s) [23] 0 0
2310 - New Lambton Heights
Recruitment postcode(s) [24] 0 0
3052 - Parkville
Recruitment postcode(s) [25] 0 0
6001 - Perth
Recruitment postcode(s) [26] 0 0
2010 - Sydney
Recruitment postcode(s) [27] 0 0
2050 - Sydney
Recruitment postcode(s) [28] 0 0
2139 - Sydney
Recruitment postcode(s) [29] 0 0
2145 - Sydney
Recruitment postcode(s) [30] 0 0
3199 - Victoria
Recruitment postcode(s) [31] 0 0
2606 - Woden
Recruitment postcode(s) [32] 0 0
2500 - Wollongong
Recruitment postcode(s) [33] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
La Plata
Country [3] 0 0
Argentina
State/province [3] 0 0
Rosario
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Mexico
State/province [8] 0 0
Guadalajara
Country [9] 0 0
Mexico
State/province [9] 0 0
Monterrey
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Hamilton
Country [12] 0 0
New Zealand
State/province [12] 0 0
Riccarton, Christchurch
Country [13] 0 0
Thailand
State/province [13] 0 0
Bangkok
Country [14] 0 0
Thailand
State/province [14] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00192647
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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