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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [1] 0 0
Weeks 48
Secondary outcome [2] 0 0
Percentage of Participants With Virological Responses Over Time
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
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
Timepoint [4] 0 0
Weeks 4, 12, and 72
Secondary outcome [5] 0 0
Change From Baseline in Log10 HCV RNA Values
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
Sex
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
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
896
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00192647