Hepatitis C, ChronicNCT00705263
Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)
An observational study of Hepatitis C, Chronic and Hepacivirus, run by Schering-Plough.
Trial summary
The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). 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
- 113 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to May 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: Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.
Who may be able to join
- Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol
Who cannot join
- Not willing to participate in the study
About this study
Official title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia
The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.
- 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, PegPen
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
Ribavirin (SCH 18908)Drug
Also called Rebetol
Peginterferon alfa-2b and ribavirin will be administered according to the products' labeling.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic hepatitis C | Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire. 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.
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.
Measured: After 4 weeks of treatment.
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 startOct 2005
- Primary completionMay 2008
- Study completionMay 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.
- 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schering-Plough
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705263
- Sponsor's protocol ID
- P04244
- Status last verified
- Aug 2009
- First submitted
- 23 Jun 2008
- Last updated
- 25 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia
- ClinicalTrials.gov ID
- NCT00705263
- Acronym / sponsor ID
- P04244
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Schering-PloughIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Posted 17 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic hepatitis C | – | Biological: Peginterferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908)Patients with chronic hepatitis C who are treated with the PegIntron pen plus Rebetol will answer questions on the patient questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.
Key inclusion criteria (1 listed)
- Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol
Key exclusion criteria (1 listed)
- Not willing to participate in the study
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: PegIntron, PegPenPeginterferon alfa-2b and ribavirin will be administered according to the products' labeling. | Biological | Patients with chronic hepatitis C |
| Ribavirin (SCH 18908)Also: RebetolPeginterferon alfa-2b and ribavirin will be administered according to the products' labeling. | Drug | Patients with chronic hepatitis C |
Primary outcome
Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
Time frame: After 4 weeks of treatment.
Participants were asked to evaluate the training they received in the proper use of the pen, the preparation and injection of the medicine, and to provide their subjective impressions about the use of the PegIntron pen. Satisfaction was defined as score 5 or above on a 7-point grading scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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 Schering-Plough.
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 25 Aug 2009. 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 17 Jul 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 Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use. (time frame: After 4 weeks 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 25 Aug 2009.