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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00623428




Registration number
NCT00623428
Ethics application status
Date submitted
18/02/2008
Date registered
26/02/2008
Date last updated
22/07/2013

Titles & IDs
Public title
A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response
Scientific title
A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response
Secondary ID [1] 0 0
2007-004993-15
Secondary ID [2] 0 0
MV21371
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 - peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Experimental: PEG-IFN alfa-2a + Ribavirin for 24 weeks - After 24 weeks of treatment with pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 µg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, at which time treatment was stopped. Participants were followed for an additional 48 weeks during the treatment-free follow-up period.

Active Comparator: PEG-IFN alfa-2a + Ribavirin for 48 weeks - After 24 weeks of treatment with PEG-IFN alfa-2a 180 µg/week plus ribavirin 800-1200 mg/day participants who achieved at least a 2-log10 drop of HCV RNA at Week 12 (as compared to HCV RNA levels prior to treatment initiation) or had HCV RNA <15 IU/mL, and who were still taking study medication at treatment Week 24 were randomized into the study, and continued treatment for another 24 weeks (for a total of 48 weeks of treatment). Participants were followed for an additional 24 weeks during the treatment-free follow-up period.


Treatment: Drugs: peginterferon alfa-2a


Treatment: Drugs: Ribavirin


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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Scheduled Completion of Treatment - Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period.
Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in the analysis.
Timepoint [1] 0 0
24 weeks after scheduled treatment completion (approximately Week 48 for participants in the 24-week treatment group and Week 72 for participants in the 48-week treatment group.
Primary outcome [2] 0 0
Percentage of Participants With a Sustained Virologic Response 24 Weeks After Actual End of Treatment - Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 24 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 24 weeks after actual end of treatment were used in the analysis. Participants without a 24-week post treatment measurement are considered non-responders.
Timepoint [2] 0 0
24 weeks after actual end of treatment (range from Week 48 to Week 72).
Secondary outcome [1] 0 0
Percentage of Participants With Virological Response 72 Weeks After Treatment Initiation - Virological response 72 weeks after treatment initiation is defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 48 weeks post completion of the 24 week treatment period and 24 weeks post completion of the 48 week treatment period.
Participants without Week 72 measurements were considered non-responders in the analysis.
Timepoint [1] 0 0
Week 72
Secondary outcome [2] 0 0
Percentage of Participants With Virological Response at End of Treatment - Virological response at the end of treatment was defined as the percentage of participants with HCV RNA <15 IU/mL as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication.
Timepoint [2] 0 0
End of Treatment (Week 24 and Week 48 for each treatment group respectively).
Secondary outcome [3] 0 0
Percentage of Participants With Virological Relapse - Virological relapse defined as the percentage of participants with a virological response at end of treatment but who did not have a sustained virological response 24 weeks after the end of treatment.
Virological response at end of treatment is defined as a single last HCV RNA measurement <15 IU/ml measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test at the day of last dose of study medication.
Sustained virological response 24 weeks after the actual treatment end (SVR24) is defined as a single last HCV RNA measurement <15 IU/ml at least 20 weeks after treatment end.
Timepoint [3] 0 0
End of treatment (Weeks 24 or 48) and 24 weeks after the end of treatment (weeks 48 and 72 in each treatment group respectively).
Secondary outcome [4] 0 0
Percentage of Participants With a Sustained Virologic Response 12 Weeks After Actual End of Treatment - Sustained virological response (SVR) is defined as a single last HCV RNA measurement <15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) at 12 weeks after actual end of study treatment. For participants in the 48-week treatment group who stopped study treatment prior to Week 48 for any reason, the HCV RNA measurements 12 weeks after actual end of treatment were used in the analysis. Participants without a 12-week post treatment measurement are considered non-responders.
Timepoint [4] 0 0
12 weeks after actual end of treatment (range from Week 36 to Week 60)
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AEs) - An AE was defined as a sign or symptom, including intercurrent illness, that occurred during the course of the clinical study after treatment had started. A related AE is an event assessed by the Investigator to be remotely, possibly, or probably related to study treatment according to criteria provided in the protocol. A severe AE was an event graded by the Investigator as "incapacitating with inability to work or perform normal daily activity". A serious AE (SAE) was defined as any experience that suggests a significant hazard, contraindication, side effect or precaution. This includes any experience which was fatal; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/ birth defect; was medically significant or required intervention to prevent one or other of the outcomes listed above.
Timepoint [5] 0 0
From Week 1 through Week 72.

Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;

- serological evidence of chronic hepatitis C (CHC);

- CHC genotype 2 or 3;

- receiving PEGASYS + Copegus according to local standard of care and no rapid viral
response (RVR);

- compensated liver disease.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to
initiation of current therapy with PEGASYS + Copegus;

- coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);

- history or other evidence of decompensated liver disease.

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 3
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
- Darlinghurst
Recruitment hospital [2] 0 0
- Fremantle
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Nedlands
Recruitment hospital [5] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6160 - Fremantle
Recruitment postcode(s) [3] 0 0
3186 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
2139 - Sydney
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
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Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
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New Jersey
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United States of America
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New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
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Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
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Utah
Country [20] 0 0
United States of America
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Virginia
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Oberndorf
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Liege
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Brazil
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Brasilia
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Brazil
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Campinas
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Rio de Janeiro
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Brazil
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Santo Andre
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Brazil
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Sao Luis
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Brazil
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Vitoria
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Düsseldorf
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Germany
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Frankfurt Am Main
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Germany
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Freiburg
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Germany
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Giessen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Kiel
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Germany
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Köln
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Germany
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Mainz
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Germany
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München
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Germany
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Offenburg
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Germany
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Tübingen
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Germany
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ULM
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Mexico
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Guadalajara
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Mexico
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Mexicali
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Mexico
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Mexico City
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Mexico
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Mexico Df
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Mexico
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Puebla
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Puerto Rico
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Santurce
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Switzerland
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St. Gallen
Country [69] 0 0
Switzerland
State/province [69] 0 0
Zürich

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 efficacy and safety of peginterferon alfa-2a 40KD + ribavirin
combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C,
genotype 2/3.
Trial website
https://clinicaltrials.gov/show/NCT00623428
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