Hepatitis C, ChronicNCT00723892
Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)
An observational study of Hepatitis C, Chronic and Hepacivirus, run by Merck Sharp & Dohme LLC.
Trial summary
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. 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 (PegIntron), Rebetol (Ribavirin) and Psychotherapy support program
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- How many people
- 614 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to May 2009
- 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: Participants at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.
Who may be able to join
- Adult patients with hepatitis C
Who cannot join
- According to the products' labeling
About this study
Official title: Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.
Read the detailed description
Enrollment of participants will occur in a sequential order of treatment initiation.
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Being tested
- Peginterferon alfa-2b (PegIntron), Rebetol (Ribavirin), Psychotherapy support program
- 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 (PegIntron)Biological
Also called PegIntron pen, SCH 54031, ViraferonPeg
Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg^kg^week
Rebetol (Ribavirin)Drug
Also called Ribavirin, SCH 18908
Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day
Psychotherapy support programBehavioural
Each site has implemented a psychotherapy support program.
| Study group | Role | What they receive |
|---|---|---|
| PegIntron/Rebetol and psychotherapy support program | Participants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. Receives: Biological: Peginterferon alfa-2b (PegIntron); Drug: Rebetol (Ribavirin); Behavioral: Psychotherapy support program | |
| PegIntron/Rebetol alone (no psychotherapy) | Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. Receives: Biological: Peginterferon alfa-2b (PegIntron); Drug: Rebetol (Ribavirin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
Measured: 12 months after onset of treatment
Secondary outcomes (1)
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
Measured: 12 months after onset of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJul 2005
- Primary completionMay 2009
- Study completionMay 2009
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
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723892
- Sponsor's protocol ID
- P04252
- Other IDs
- MK-4031-245
- Status last verified
- Oct 2015
- First submitted
- 25 Jul 2008
- Last updated
- 30 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 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory on Treatment Adhesion in Patients Suffering From Hepatitis C Chronic Treated With ViraferonPeg® Injected / Rebetol® in Conjunction With a Psychotherapeutic Assistance Program
- ClinicalTrials.gov ID
- NCT00723892
- Acronym / sponsor ID
- P04252
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 20 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.
Detailed description
Enrollment of participants will occur in a sequential order of treatment initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PegIntron/Rebetol and psychotherapy support program | – | Biological: Peginterferon alfa-2b (PegIntron), Drug: Rebetol (Ribavirin), Behavioral: Psychotherapy support programParticipants receiving a psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
| PegIntron/Rebetol alone (no psychotherapy) | – | Biological: Peginterferon alfa-2b (PegIntron), Drug: Rebetol (Ribavirin)Participants receiving no psychotherapy support program during PegIntron/Rebetol therapy for hepatitis C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at sites in France who are receiving a psychotherapy support program during therapy for hepatitis C and a control group without a psychotherapy support program.
Key inclusion criteria (1 listed)
- Adult patients with hepatitis C
Key exclusion criteria (1 listed)
- According to the products' labeling
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 (PegIntron)Also: PegIntron pen, SCH 54031, ViraferonPegPeginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg^kg^week | Biological | PegIntron/Rebetol alone (no psychotherapy), PegIntron/Rebetol and psychotherapy support program |
| Rebetol (Ribavirin)Also: Ribavirin, SCH 18908Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg^day | Drug | PegIntron/Rebetol alone (no psychotherapy), PegIntron/Rebetol and psychotherapy support program |
| Psychotherapy support programEach site has implemented a psychotherapy support program. | Behavioural | PegIntron/Rebetol and psychotherapy support program |
Primary outcome
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program.
Time frame: 12 months after onset of treatment
1 secondary outcome
the Average Length of Treatment for Participants on Treatment for Hepatitis C With PegIntron Pen/Rebetol
Time frame: 12 months after onset of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Medical Director study director
Merck Sharp & Dohme LLC
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 30 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 20 Sep 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?
Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C When Administered With a Patient Psychotherapy Support Program as Compared to a Group Without a Psychotherapy Support Program. (time frame: 12 months after onset of treatment). 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 30 Oct 2015.