Chronic Hepatitis CPhase 2NCT00332176
A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C
A Phase 2 study testing Celgosivir and Peginterferon alfa 2b + ribavirin in people with Chronic Hepatitis C, run by BioWest Therapeutics Inc at 3 sites in Canada.
Trial summary
The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Celgosivir and Peginterferon alfa 2b + ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2006to Dec 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age, inclusive
- primary diagnosis of chronic HCV infection, genotype 1
- Interferon-based treatment-naïve
- Body Mass Index of 18 to 30, inclusive
Who cannot join
- patients previously treated with Interferon-based therapy
- patients with diabetes mellitus
Trial locations and contacts
3 sites in 1 country.
Jim Pankovich contact
Canada3 sites, 2 recruiting
- Recruiting
Biovail Contract Research
Toronto, Ontario, M1L 4S4
- Recruiting
Liver and Intestinal Research Centre
Vancouver, British Columbia, V5Z 1H2
- Completed
Cantest
Vancouver, British Columbia, V5Z 1H6
About this study
Official title: A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C
The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.
- Conditions
- Chronic Hepatitis C
- Being tested
- Celgosivir, Peginterferon alfa 2b + ribavirin
- Keywords
- Hepatitis C, Celgosivir, HCV, Genotype 1, Treatment-naive, Early viral kinetics
- 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.
CelgosivirDrug
400mg qd + standard of care for 12 weeks
CelgosivirDrug
600mg qd + standard of care for 12 weeks
Peginterferon alfa 2b + ribavirinDrug
Standard of care for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Celgosivir |
| 2 | Experimental | Not described Receives: Drug: Celgosivir |
| 3 | Active comparator | Not described Receives: Drug: Peginterferon alfa 2b + ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety analysis
Measured: 12 weeks
HCV viral load
Measured: 12 weeks
Pharmacokinetics of celgosivir/castanospermine
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioWest Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Pankovich, Study director, BioWest Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332176
- Sponsor's protocol ID
- HCV-06-001
- Status last verified
- Apr 2008
- First submitted
- 30 May 2006
- Last updated
- 8 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00332176
- Acronym / sponsor ID
- HCV-06-001
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Celgosivir, HCV, Genotype 1, Treatment-naive, Early viral kinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BioWest Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 1 Jun 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 objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Celgosivir |
| 2 | Experimental | Drug: Celgosivir |
| 3 | Active comparator | Drug: Peginterferon alfa 2b + ribavirin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age, inclusive
- primary diagnosis of chronic HCV infection, genotype 1
- Interferon-based treatment-naïve
- Body Mass Index of 18 to 30, inclusive
Key exclusion criteria (2 listed)
- patients previously treated with Interferon-based therapy
- patients with diabetes mellitus
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 |
|---|---|---|
| Celgosivir400mg qd + standard of care for 12 weeks | Drug | 1 |
| Celgosivir600mg qd + standard of care for 12 weeks | Drug | 2 |
| Peginterferon alfa 2b + ribavirinStandard of care for 12 weeks | Drug | 3 |
Primary outcome
Safety analysis
Time frame: 12 weeks
HCV viral load
Time frame: 12 weeks
Pharmacokinetics of celgosivir/castanospermine
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2008.
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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.
Jim Pankovich contact
Jim Pankovich study director
BioWest Therapeutics Inc
3 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 Celgosivir and Peginterferon alfa 2b + ribavirin in people with Chronic Hepatitis C, run by BioWest Therapeutics Inc at 3 sites in Canada.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jim Pankovich (604-221-9666 ext. 259), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety analysis (time frame: 12 weeks). The study lists 3 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 8 Apr 2008.