Hepatitis CPhase 2NCT00262483
Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C
A Phase 2 study testing VX-950, ribavirin and peginterferon alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 2 sites in 2 countries.
Trial summary
To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C. 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?
- VX-950, ribavirin and peginterferon alfa-2a
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2005to Apr 2006
- 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
- Infected with hepatitis C virus
Who cannot join
- Contraindications to peginterferon or ribavirin therapy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C
To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- VX-950, ribavirin, peginterferon alfa-2a
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-950Drug
ribavirinDrug
peginterferon alfa-2aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of triple combination therapy.
Measured: retrospective and prospective
Secondary outcomes (2)
Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.
Measured: retrospective and prospective
Plasma HCV RNA levels
Measured: retrospective and prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startDec 2005
- Study completionApr 2006
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.
- More trials run by Vertex Pharmaceuticals IncorporatedThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262483
- Sponsor's protocol ID
- VX05-950-102
- Status last verified
- Dec 2007
- First submitted
- 2 Dec 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C
- ClinicalTrials.gov ID
- NCT00262483
- Acronym / sponsor ID
- VX05-950-102
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 6 Dec 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.
To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infected with hepatitis C virus
Key exclusion criteria (1 listed)
- Contraindications to peginterferon or ribavirin therapy.
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 |
|---|---|---|
| VX-950 | Drug | – |
| ribavirin | Drug | – |
| peginterferon alfa-2a | Drug | – |
Primary outcome
Safety of triple combination therapy.
Time frame: retrospective and prospective
2 secondary outcomes
Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin.
Time frame: retrospective and prospective
Plasma HCV RNA levels
Time frame: retrospective and prospective
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 21 Dec 2007.
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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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
2 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 VX-950, ribavirin and peginterferon alfa-2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 2 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 1 inclusion and 1 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 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Safety of triple combination therapy. (time frame: retrospective and prospective). 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 21 Dec 2007.