Hepatitis C, ChronicNCT00705107
Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIntron pen (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908)
- How many people
- 267 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Nov 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Who may be able to join
- Treatment-naïve patients with hepatitis C
- Patients treated with PegIntron pen and Rebetol
- Patients receiving patient assistance program
Who cannot join
- Not applicable
About this study
Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron pen (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- 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.
PegIntron pen (peginterferon alfa-2b; SCH 54031)Biological
Also called SCH 54031
PegIntron administered in accordance with approved labeling.
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered in accordance with approved labeling
| Study group | Role | What they receive |
|---|---|---|
| All Treated Patients | All patients participating in the study Receives: Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Completed Treatment.
Measured: Assessed at the end of the 48-week treatment.
Secondary outcomes (1)
Average Length of Treatment.
Measured: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startNov 2004
- Primary completionNov 2007
- Study completionNov 2007
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 267 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
- NCT00705107
- Sponsor's protocol ID
- P04247
- Status last verified
- Jun 2015
- First submitted
- 23 Jun 2008
- Last updated
- 30 Jun 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 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
- ClinicalTrials.gov ID
- NCT00705107
- Acronym / sponsor ID
- P04247
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Posted 2 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Treated Patients | – | Biological: PegIntron pen (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)All patients participating in the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).
Key inclusion criteria (3 listed)
- Treatment-naïve patients with hepatitis C
- Patients treated with PegIntron pen and Rebetol
- Patients receiving patient assistance program
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| PegIntron pen (peginterferon alfa-2b; SCH 54031)Also: SCH 54031PegIntron administered in accordance with approved labeling. | Biological | All Treated Patients |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered in accordance with approved labeling | Drug | All Treated Patients |
Primary outcome
Number of Subjects Who Completed Treatment.
Time frame: Assessed at the end of the 48-week treatment.
1 secondary outcome
Average Length of Treatment.
Time frame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 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 Hepatitis C, 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 3 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: stopped early, as of the sponsor's last update on 30 Jun 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 2 Jun 2009). 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 Subjects Who Completed Treatment. (time frame: Assessed at the end of the 48-week 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 Jun 2015.