Hepatitis C, ChronicNCT00725205
Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIntron (Peginterferon alfa-2b) and Rebetol (Ribavirin)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Oct 2010
- 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: Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study.
Who may be able to join
- Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.
Who cannot join
- According to Peginterferon alfa-2b/Ribavirin label.
About this study
Official title: Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron (Peginterferon alfa-2b), Rebetol (Ribavirin)
- 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 (Peginterferon alfa-2b)Biological
Also called PegIntron, SCH 54031
Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms [mcg]/killogram [kg]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
Rebetol (Ribavirin)Drug
Also called Rebetol, SCH 18908
Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype.
| Study group | Role | What they receive |
|---|---|---|
| Chronic hepatitis C participants | Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study. Receives: Biological: PegIntron (Peginterferon alfa-2b); Drug: Rebetol (Ribavirin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Are Triple-80 Compliant
Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.
Measured: 24 or 48 Weeks
Secondary outcomes (2)
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
Sustained virologic response (SVR) was assessed at post-treatment Follow-up Week 24. Day 1 of the Follow-up period was defined as the first day after the last dose day. A participant was considered a sustained responder if the participant had undetectable Hepatitis C virus Ribonucleic acid (HCV-RNA) level (based on qualitative test result) at Follow-up Week 24. If a participant with missing polymerase chain reaction (PCR) data at Follow-up Week 24 had undetectable HCV-RNA level at Follow-up Week 12, the participant was also considered as a sustained responder.
Measured: 24 Weeks following completion of 24 or 48 weeks of therapy
Number Of Participants Self-Administering Pegylated Interferon Alfa-2b
Number of participants self-administering Pegylated interferon alfa-2b injection pen. If a participant changed the way he or she administered the injection pen during the course of the study (from self-administering to clinic-administering or the other way around), that participant was also considered as self-administering.
Measured: Up to 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startMar 2006
- Primary completionOct 2010
- Study completionOct 2010
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
- 294 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
- NCT00725205
- Sponsor's protocol ID
- P04690
- Status last verified
- Oct 2015
- First submitted
- 25 Jul 2008
- Last updated
- 8 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 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00725205
- Acronym / sponsor ID
- P04690
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 18 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hepatitis C participants | – | Biological: PegIntron (Peginterferon alfa-2b), Drug: Rebetol (Ribavirin)Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study.
Key inclusion criteria (1 listed)
- Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.
Key exclusion criteria (1 listed)
- According to Peginterferon alfa-2b/Ribavirin label.
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 (Peginterferon alfa-2b)Also: PegIntron, SCH 54031Peginterferon alfa-2b (injection pen) administered according to the product's labeling and current practice in Hungary (1.5 micrograms [mcg]/killogram [kg]) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype. | Biological | Chronic hepatitis C participants |
| Rebetol (Ribavirin)Also: Rebetol, SCH 18908Ribavirin capsules administered according to the product's labeling and current practice in Hungary (weight based daily) for 12 weeks. Those participants whose continued treatment was warranted beyond week 12 based on response received therapy for 24 or 48 weeks depending on the viral genotype. | Drug | Chronic hepatitis C participants |
Primary outcome
Number of Participants Who Are Triple-80 Compliant
Time frame: 24 or 48 Weeks
Participants who continued treatment beyond Week 12 (i.e., 24 or 48 weeks depending on the viral genotype) were assessed for triple-80 compliance. Triple-80 compliant, or simply compliant, participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b and ribavirin for >=80% of the duration of the therapy. 3 rates were computed: Compliance with study duration, compliance with pegylated interferon dose, and compliance with ribavirin dose. A participant was defined as triple-80 compliant, if none of the 3 rates as defined above were less than 80.
2 secondary outcomes
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
Time frame: 24 Weeks following completion of 24 or 48 weeks of therapy
Number Of Participants Self-Administering Pegylated Interferon Alfa-2b
Time frame: Up to 48 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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 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 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 8 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 18 Nov 2011). 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 Are Triple-80 Compliant (time frame: 24 or 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 8 Oct 2015.