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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00093093




Registration number
NCT00093093
Ethics application status
Date submitted
30/09/2004
Date registered
4/10/2004
Date last updated
22/06/2012

Titles & IDs
Public title
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment Naive
Scientific title
Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
Secondary ID [1] 0 0
RNA003142-302
Universal Trial Number (UTN)
Trial acronym
VISER2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 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 - Viramidine
Treatment: Drugs - Ribavirin
Treatment: Drugs - pegylated interferon alfa-2a

Treatment: Drugs: Viramidine


Treatment: Drugs: Ribavirin


Treatment: Drugs: pegylated interferon alfa-2a


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

Outcomes
Primary outcome [1] 0 0
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
Timepoint [1] 0 0
Primary outcome [2] 0 0
- Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
- Efficacy: Undetectable plasma HCV RNA at treatment week 24
Timepoint [1] 0 0
Secondary outcome [2] 0 0
- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
Timepoint [2] 0 0
Secondary outcome [3] 0 0
- Safety: Monitoring of adverse events
Timepoint [3] 0 0
Secondary outcome [4] 0 0
- Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Treatment-naive patients with compensated chronic hepatitis C.

- HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA
quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe neuropsychiatric disorders

- History or clinical manifestations of significant metabolic, hematological, pulmonary,
ischemic heart disease, significant or unstable heart disease, gastrointestinal,
neurological, renal, urological, endocrine, ophthalmologic disorders including severe
retinopathy, or immune mediated disease

- Pregnant or breast-feeding patients

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
Blinded (masking 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)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [4] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
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United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
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United States of America
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Illinois
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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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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
Country [13] 0 0
United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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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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Oklahoma
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Pennsylvania
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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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Argentina
State/province [25] 0 0
BA
Country [26] 0 0
Argentina
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Santa Fe
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Canada
State/province [27] 0 0
Alberta
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Canada
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Manitoba
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Canada
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Ontario
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France
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Grenoble
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France
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Marseille
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France
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Nice
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France
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Paris
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France
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Vandouevre les Nancy
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Israel
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Haifa
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Israel
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Nazareth
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Israel
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Tel Aviv
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Italy
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Busto Arsizio
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Italy
State/province [39] 0 0
Palermo
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Italy
State/province [40] 0 0
Pavia
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Italy
State/province [41] 0 0
Rome
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Italy
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Torino
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Krakow
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Poland
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Szczecin
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Poland
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Warszawa
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Puerto Rico
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Santurce
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Russian Federation
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Moscow
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Russian Federation
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Smolensk
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Russian Federation
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St.Petersburg
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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Birmingham
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United Kingdom
State/province [57] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bausch Health Americas, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine the safety and effectiveness of viramidine to
ribavirin in chronic hepatitis C patients who have never before received treatment.
Trial website
https://clinicaltrials.gov/show/NCT00093093
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ralph T. Doyle
Address 0 0
Bausch Health Americas, Inc.
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