Chronic Hepatitis CPhase 3NCT00230958
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive
A Phase 3 study testing Viramidine, Ribavirin and pegylated interferon alfa-2b in people with Chronic Hepatitis C, run by Bausch Health Americas, Inc..
Trial summary
This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Viramidine, Ribavirin and pegylated interferon alfa-2b
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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, opthalmologic disorders including severe retinopathy, or immune mediated disease
- Pregnant or breast-feeding patients
About this study
Official title: Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.
Read the detailed description
Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)
- Conditions
- Chronic Hepatitis C
- Being tested
- Viramidine, Ribavirin, pegylated interferon alfa-2b
- Keywords
- Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2b
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViramidineDrug
RibavirinDrug
pegylated interferon alfa-2bDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
- 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.
Secondary outcomes (4)
- Efficacy: Undetectable plasma HCV RNA at treatment week 24
- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
- Safety: Monitoring of adverse events
- Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startDec 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph T. Doyle, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230958
- Sponsor's protocol ID
- RNA003142-301
- Status last verified
- Jun 2012
- First submitted
- 29 Sep 2005
- Last updated
- 22 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00230958
- Acronym / sponsor ID
- RNA003142-301
- Conditions
- Chronic Hepatitis C
- Keywords
- Viramidine, Ribavirin, Valeant, Hepatitis C, Pegylated interferon alfa-2b
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 3 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.
Detailed description
Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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, opthalmologic disorders including severe retinopathy, or immune mediated disease
- Pregnant or breast-feeding patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viramidine | Drug | – |
| Ribavirin | Drug | – |
| pegylated interferon alfa-2b | Drug | – |
Primary outcome
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.
- 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.
4 secondary outcomes
- Efficacy: Undetectable plasma HCV RNA at treatment week 24
- Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24
- Safety: Monitoring of adverse events
- Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph T. Doyle study director
Bausch Health Americas, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viramidine, Ribavirin and pegylated interferon alfa-2b in people with Chronic Hepatitis C, run by Bausch Health Americas, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.