Hepatitis C, ChronicADEQUATIONNCT00705666
Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)
An observational study of Hepatitis C, Chronic and Hepacivirus, run by Merck Sharp & Dohme LLC.
Trial summary
In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Hepacivirus
- What is being tested?
- Peginterferon alfa-2b (SCH 54031) and Ribavirin (SCH 18908)
- How many people
- 789 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Jul 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin at academic centers, clinics, and private practices in France.
Who may be able to join
- Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C.
Who cannot join
- Concomitant participation in a clinical trial for the treatment of hepatitis C.
About this study
Official title: Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C
In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.
Read the detailed description
To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Being tested
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2b (SCH 54031)Biological
Also called PegIntron
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
Ribavirin (SCH 18908)Drug
Also called Rebetol
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
| Study group | Role | What they receive |
|---|---|---|
| PegIntron as monotherapy or in combination with Ribavirin. | Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. Receives: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).
Measured: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startFeb 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705666
- Sponsor's protocol ID
- P04437
- Acronym
- ADEQUATION
- Status last verified
- Oct 2015
- First submitted
- 23 Jun 2008
- Last updated
- 2 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00705666
- Acronym / sponsor ID
- ADEQUATION / P04437
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 24 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.
Detailed description
To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegIntron as monotherapy or in combination with Ribavirin. | – | Biological: Peginterferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908)Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin at academic centers, clinics, and private practices in France.
Key inclusion criteria (1 listed)
- Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C.
Key exclusion criteria (1 listed)
- Concomitant participation in a clinical trial for the treatment of hepatitis C.
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 |
|---|---|---|
| Peginterferon alfa-2b (SCH 54031)Also: PegIntronPeginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling. | Biological | PegIntron as monotherapy or in combination with Ribavirin. |
| Ribavirin (SCH 18908)Also: RebetolPeginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling. | Drug | PegIntron as monotherapy or in combination with Ribavirin. |
Primary outcome
The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).
Time frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Hepacivirus, run by Merck Sharp & Dohme LLC.
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 2 Oct 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). (time frame: Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 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 2 Oct 2015.