Hepatitis CPhase 2NCT00367887
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
A Phase 2 study testing Peg-Intron, REBETOL and HCV 796 in people with Hepatitis C, run by Wyeth is now a wholly owned subsidiary of Pfizer at 35 sites in 2 countries.
Trial summary
This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Peg-Intron, REBETOL and HCV 796
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Oct 2006to Jul 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
- Infection with HCV genotype 1.
- HCV- infected subjects naive to treatment.
- HCV-infected non-responder subjects.
Who cannot join
- Women who are pregnant or breastfeeding.
- ALT >/ or = 5X the upper limit of normal.
- AST >/ or = 5X the upper limit of normal.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
United States34 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87131
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Annandale, Virginia, 22003
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7209
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Fairfax, Virginia, 22031
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92067
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141
Pfizer Investigational Site
Plymouth, Minnesota, 55446
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
Saint Paul, Minnesota, 55117
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Diego, California, 92161
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94121
Pfizer Investigational Site
St Louis, Missouri, 63104
Pfizer Investigational Site
The Bronx, New York, 10461
Pfizer Investigational Site
The Bronx, New York, 10468
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
Worcester, Massachusetts, 01655
About this study
Official title: A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection
This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype
1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).
- Conditions
- Hepatitis C
- Being tested
- Peg-Intron, REBETOL, HCV 796
- Keywords
- Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-IntronDrug
SC injection, weight based dosing, weekly, 48 weeks
REBETOLDrug
Capsules, weight based dosing, Q12 hrs daily, 48weeks
HCV 796Drug
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Peg-IntronDrug
SC injection, weight based dosing, weekly, 48 weeks
REBETOLDrug
Capsules, weight based dosing, Q12 hrs daily, 48weeks
HCV 796Drug
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Peg-IntronDrug
SC injection, weight based dosing, weekly, 48 weeks
REBETOLDrug
Capsules, weight based dosing, Q12 hrs daily, 48weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Peg-Intron; Drug: REBETOL |
| 2 | Active comparator | Not described Receives: Drug: HCV 796; Drug: Peg-Intron; Drug: REBETOL |
| 3 | Active comparator | Not described Receives: Drug: HCV 796; Drug: Peg-Intron; Drug: REBETOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis C Virus (HCV) RNA concentrations in the blood.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViroPharma
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367887
- Sponsor's protocol ID
- 3173A1-200
- Other IDs
- B3381001
- Status last verified
- Feb 2013
- First submitted
- 21 Aug 2006
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection
- ClinicalTrials.gov ID
- NCT00367887
- Acronym / sponsor ID
- 3173A1-200
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- ViroPharma
- Study start
- Oct 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 23 Aug 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.
This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype
1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Peg-Intron, Drug: REBETOL |
| 2 | Active comparator | Drug: HCV 796, Drug: Peg-Intron, Drug: REBETOL |
| 3 | Active comparator | Drug: HCV 796, Drug: Peg-Intron, Drug: REBETOL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Infection with HCV genotype 1.
- HCV- infected subjects naive to treatment.
- HCV-infected non-responder subjects.
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding.
- ALT >/ or = 5X the upper limit of normal.
- AST >/ or = 5X the upper limit of normal.
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 |
|---|---|---|
| Peg-IntronSC injection, weight based dosing, weekly, 48 weeks | Drug | 1 |
| REBETOLCapsules, weight based dosing, Q12 hrs daily, 48weeks | Drug | 1 |
| HCV 796Capsules, 500 mg, Q 12 hrs. daily, 48 weeks | Drug | 2 |
| Peg-IntronSC injection, weight based dosing, weekly, 48 weeks | Drug | 2 |
| REBETOLCapsules, weight based dosing, Q12 hrs daily, 48weeks | Drug | 2 |
| HCV 796Capsules, 500 mg, Q 12 hrs. daily, 48 weeks | Drug | 3 |
| Peg-IntronSC injection, weight based dosing, weekly, 48 weeks | Drug | 3 |
| REBETOLCapsules, weight based dosing, Q12 hrs daily, 48weeks | Drug | 3 |
Primary outcome
Hepatitis C Virus (HCV) RNA concentrations in the blood.
Time frame: 72 weeks
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 11 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peg-Intron, REBETOL and HCV 796 in people with Hepatitis C, run by Wyeth is now a wholly owned subsidiary of Pfizer at 35 sites in 2 countries.
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 3 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Puerto Rico. 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 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?
Hepatitis C Virus (HCV) RNA concentrations in the blood. (time frame: 72 weeks). 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 11 Feb 2013.