Hepatitis C, ChronicNCT00723879
Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)
An observational study of Hepatitis C, Chronic and Hepacivirus, run by Merck Sharp & Dohme LLC.
Trial summary
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other… 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), Ribavirin (SCH 18908) and Patient assistance program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature.
Who may be able to join
- Patients with chronic hepatitis C naive to treatment
Who cannot join
- None
About this study
Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Being tested
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908), Patient assistance 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 (SCH 54031)Biological
Also called PegIntron
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.
Patient assistance programBehavioural
Patient assistance programs will be classified as follows:
- medications, including psychiatric medications (antidepressants);
- other interventions, including nurse telephone calls and nurse support in the office: and
- educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatitis C | Patients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program. Receives: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908); Behavioral: Patient assistance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.
Measured: NA (i.e. the study was terminated)
Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.
Measured: NA (i.e. the study was terminated)
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 startOct 2004
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 115 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
- NCT00723879
- Sponsor's protocol ID
- P04206
- Status last verified
- Nov 2015
- First submitted
- 25 Jul 2008
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence Rate in Patients Receiving PegIntron / Rebetol (Weight Based) for Hepatitis C in Conjunction With a Patient Assistance Program.
- ClinicalTrials.gov ID
- NCT00723879
- Acronym / sponsor ID
- P04206
- Conditions
- Hepatitis C, Chronic, Hepacivirus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients)
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatitis C | – | Biological: Peginterferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908), Behavioral: Patient assistance programPatients receiving a patient assistance program during therapy for hepatitis C will be enrolled into this study. All patients will receive PegIntron plus Rebetol (according to the label) and the patient assistance program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature.
Key inclusion criteria (1 listed)
- Patients with chronic hepatitis C naive to treatment
Key exclusion criteria (1 listed)
- None
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 and ribavirin will be administered according to the products' labeling. | Biological | Patients with hepatitis C |
| Ribavirin (SCH 18908)Also: RebetolPeginterferon alfa-2b and ribavirin will be administered according to the products' labeling. | Drug | Patients with hepatitis C |
| Patient assistance programPatient assistance programs will be classified as follows: 1. medications, including psychiatric medications (antidepressants); 2. other interventions, including nurse telephone calls and nurse support in the office: and 3. educational literature about hepatitis C containing information about the disease, mode of transmission, complications, and treatment and treatment drawbacks that will be given to each patient at the start of treatment. | Behavioural | Patients with hepatitis C |
Primary outcome
Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program.
Time frame: NA (i.e. the study was terminated)
Average length of treatment for patients receiving a patient assistance program as part of their treatment for hepatitis C with PegIntron plus Rebetol.
Time frame: NA (i.e. the study was terminated)
Results and safety
The study was stopped early (reason given: Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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: stopped early, as of the sponsor's last update on 3 Nov 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?
The study was stopped early (reason given: Because of slow recruitment; Despite the study was started long time ago (Oct 2004), we have not reached the projected number of patients (150 patients)). Results are not available in the source record.
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?
Proportion of patients who complete treatment with PegIntron plus Rebetol therapy for hepatitis C when administered with a patient assistance program. (time frame: NA (i.e. the study was terminated)). The study lists 2 primary outcomes in all. 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 3 Nov 2015.