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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01853254




Registration number
NCT01853254
Ethics application status
Date submitted
10/05/2013
Date registered
14/05/2013
Date last updated
4/09/2013

Titles & IDs
Public title
A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials
Scientific title
An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
Secondary ID [1] 0 0
NV17590
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: Peginterferon alfa-2a monotherapy or combined with ribavirin - The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.


Treatment: Drugs: Peginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 µg subcutaneously once weekly.

Treatment: Drugs: Ribavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing = 75 kg, in 2 split doses, 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 at Least 1 Adverse Event
Timepoint [1] 0 0
From Baseline to the end of the study (up to 72 weeks)

Eligibility
Key inclusion criteria
* Adult patients, = 18 years of age.
* Chronic hepatitis C.
* Compensated liver disease (Child-Pugh Class A).
* Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.
* Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.
* Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.
* For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.
* Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding women.
* Male partners of women who are pregnant.
* Patients with hemoglobinopathies.
* Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.
* Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).
* Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
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
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Herston
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
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United States of America
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Idaho
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
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Minnesota
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Brazil
State/province [25] 0 0
Ribeirao Preto
Country [26] 0 0
Brazil
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Salvador
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Brazil
State/province [27] 0 0
Sao Paulo
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France
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Vandoeuvre-les-nancy
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Greece
State/province [29] 0 0
Thessaloniki
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Italy
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Bergamo
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Italy
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Napoli
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Poland
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Warszawa
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Puerto Rico
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Santurce
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Spain
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Barcelona
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Taiwan
State/province [37] 0 0
Taoyuan
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01853254