Hepatitis C, ChronicPhase 2NCT00305383
Viral Kinetic Study With Viramidine in Therapy-Naive Patients With Chronic Hepatitis C
A Phase 2 study testing Viramidine and Peginterferon alfa-2b in people with Hepatitis C, Chronic, run by Bausch Health Americas, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Viramidine and Peginterferon alfa-2b
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2005to May 2007
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
- Body weight greater than 61 kg and not more than 87.3 kg
- HCV RNA greater than 2 million copies/mL
- Elevated measured or historical alanine aminotransferase
- Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
- Calculated creatinine clearance greater than 70 mL/min
Who cannot join
- Cirrhosis of the liver
- Alanine aminotransferase greater than 3 times the upper limit of normal
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Bach and Godofsky
Bradenton, Florida, 34205
Atlantic Gastroenterology Associates
Egg Harbor, New Jersey, 08234
Metropolitan Research -- Georgetown Medical Center
Fairfax, Virginia, 22031
Maryland Digestive Disease Research
Laurel, Maryland, 20707
University of Southern California -- Keck School of Medicine
Los Angeles, California, 90033
University of Miami -- Center for Liver Diseases
Miami, Florida, 33136
Thomas Jefferson University -- Gastroenterology and Hepatology
Philadelphia, Pennsylvania, 19107
Liver Center of Long Island
Plainview, New York, 11803
Mountain West Gastroenterology -- Research Office
Salt Lake City, Utah, 84121
San Mateo Medical Center
San Mateo, California, 94403
About this study
Official title: Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C
The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.
Read the detailed description
This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Viramidine, Peginterferon alfa-2b
- Keywords
- Viramidine, Peginterferon alfa-2b, Valeant, Hepatitis C, Rapid virologic response, HCV RNA
- 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
Peginterferon alfa-2bDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group.
Safety: Evaluation of adverse events (AEs).
Safety: Physical exams
Safety: Vital signs
Safety: Laboratory tests
Secondary outcomes (1)
Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startNov 2005
- Study completionMay 2007
Why it stopped: Dose levels were determined to be subtherapeutic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 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
- NCT00305383
- Sponsor's protocol ID
- RNA003142-202
- Status last verified
- Jun 2012
- First submitted
- 17 Mar 2006
- 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
- Analysis of Hepatitis C Viral Kinetics and Viramidine Pharmacokinetics Utilizing Two Treatment Regimens in Therapy-Naive Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00305383
- Acronym / sponsor ID
- RNA003142-202
- Conditions
- Hepatitis C, Chronic
- Keywords
- Viramidine, Peginterferon alfa-2b, Valeant, Hepatitis C, Rapid virologic response, HCV RNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dose levels were determined to be subtherapeutic
- Enrolment
- 100 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- May 2007 (actual)
- First posted
- 21 Mar 2006 (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.
The purpose of this study is to examine the rapid virologic response (RVR) at combination therapy (CT) Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy.
Detailed description
This Phase 2b multicenter study, which is being conducted solely in the United States, consists of a randomized, double-blind, monotherapy period, where patients will receive either viramidine or placebo for 4 weeks. After the monotherapy period, all patients will receive viramidine plus peginterferon alfa-2b combination therapy for 48 weeks in an open-label fashion and will then participate in a 24-week follow-up period after completion of combination therapy. The RVR at CT Week 4 between groups receiving a standard combination peginterferon alfa-2b/viramidine dosing regimen versus a cohort that receives 4 weeks of viramidine monotherapy prior to the start of peginterferon alfa-2b/viramidine combination therapy will be examined. The differences in virological response during treatment and end of follow-up between African-Americans and Caucasians (non-Hispanics), as well as a correlation between duration of viral negativity (DVN) and sustained virologic response (SVR) based on race and dosing regimen, will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Treatment-naive, genotype 1 only, compensated, chronic hepatitis C infected Caucasian or African-American patients
- Body weight greater than 61 kg and not more than 87.3 kg
- HCV RNA greater than 2 million copies/mL
- Elevated measured or historical alanine aminotransferase
- Hemoglobin at least 12.0 g/dL for females and at least 13.0 g/dL for males
Key exclusion criteria (5 listed)
- Cirrhosis of the liver
- Alanine aminotransferase greater than 3 times the upper limit of normal
- Severe neuropsychiatric disorders
- History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease
- Other co-morbid chronic viral infections including hepatitis B and the human immunodeficiency virus (HIV)
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 | – |
| Peginterferon alfa-2b | Drug | – |
Primary outcome
Efficacy: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group.
Safety: Evaluation of adverse events (AEs).
Safety: Physical exams
Safety: Vital signs
Safety: Laboratory tests
1 secondary outcome
Efficacy: HCV RNA Response at CT Week 12, 24, end of treatment and at follow-up Week 24.
Results and safety
The study was stopped early (reason given: Dose levels were determined to be subtherapeutic). Results are not available in the source record.
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viramidine and Peginterferon alfa-2b in people with Hepatitis C, Chronic, run by Bausch Health Americas, Inc. at 11 sites in United States.
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 6 inclusion and 5 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: stopped early, 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.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Dose levels were determined to be subtherapeutic). Results are not available in the source record.
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: The proportion of patients with hepatitis C virus (HCV) RNA undetectable or with at least a 2-log drop from baseline at CT Week 4 in the viramidine pre-load group versus the viramidine standard dosing group.. The study lists 5 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.