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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
N/A
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
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United States of America
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Alabama
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California
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Colorado
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Florida
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Georgia
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Hawaii
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Idaho
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Indiana
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Iowa
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Kansas
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Maryland
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Massachusetts
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Minnesota
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New Jersey
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New York
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North Carolina
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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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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Brazil
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Ribeirao Preto
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Brazil
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Salvador
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Brazil
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Sao Paulo
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France
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Vandoeuvre-les-nancy
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Greece
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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
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Taoyuan
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United Kingdom
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Plymouth

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

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, non-randomized, single arm study will provide treatment or re-treatment with
Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to
patients with chronic hepatitis C infection. Patients who have received prior Pegasys
monotherapy or combination therapy or who were considered eligible for treatment with Pegasys
in previous donor protocols will be eligible to participate in this study. Treatment will be
on investigator's decision according to the approved label for up to 48 weeks, with a 24-week
safety follow-up.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01853254
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/ct2/show/NCT01853254