Hepatitis C, ChronicNCT00704522

Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

An observational study of Hepatitis C, Chronic and Hepacivirus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 601 participants
Where: No sites listed yet
Study dates: Mar 2005to Apr 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: Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

Who may be able to join

Adult patients with hepatitis C

Who cannot join

According to the products' labeling (refer to Warnings, contraindications, and safety sections).

About this study

Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol 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 pen and Rebetol according to label and the patient assistance program. 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, PegIntron pen
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
Assistance programs will be classified as follows:
1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications)
2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature).
In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.

Study groups in NCT00704522
Study group	Role	What they receive
Patients with hepatitis C		Patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria. 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.

Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
Measured: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Average Length of Treatment With PegIntron/Rebetol
Measured: After start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Apr 2009

First posted25 Jun 2008 (estimated)
Study startMar 2005
Primary completionApr 2009
Study completionApr 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: 601 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704522
Sponsor's protocol ID: P04281
Status last verified: Oct 2015
First submitted: 23 Jun 2008
Last updated: 6 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 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 in Conjunction With a Patient Assistance Program.
ClinicalTrials.gov ID: NCT00704522
Acronym / sponsor ID: P04281
Conditions: Hepatitis C, Chronic, Hepacivirus
Study type: Observational
Recruitment status: Completed
Enrolment: 601 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 25 Jun 2008 (estimated)
Results: Posted 17 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 at sites in Austria.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients receiving a patient assistance program during therapy for hepatitis C at sites in Austria.

Key inclusion criteria (1 listed)

Adult patients with hepatitis C

Key exclusion criteria (1 listed)

According to the products' labeling (refer to Warnings, contraindications, and safety sections).

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, PegIntron penPeginterferon 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 programAssistance programs will be classified as follows: 1. Medications used prophylactically or for treatment(Growth factors: RBC and neutrophil; Psychiatric medications; Other medications) 2. Other interventions (Psychotherapy, Patient Support Groups, Visiting Nurse, Nurse Telephone Calls, Nurse support in office, Other health care professional support, Educational Literature). In Austria, sites with adherence nurses and side effect handouts will be compared with sites using side effect handouts only.	Behavioural	Patients with hepatitis C

Primary outcome

Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program
Time frame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up
Average Length of Treatment With PegIntron/Rebetol
Time frame: After start of treatment

Results and safety

Results posted to the registry on 17 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PegIntron Pen/Rebetol Without Patient Assistance Program	481	298
PegIntron Pen/Rebetol With Patient Assistance Program	120	75

Primary outcome: Number of Participants Who Complete Treatment With PegIntron Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program

Time frame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up. Number. Unit: Participants

Measure	PegIntron Pen/Rebetol Without Patient Assistance Program n = 481	PegIntron Pen/Rebetol With Patient Assistance Program n = 120
Value	298	75

Population analysed: All participants

Primary outcome: Average Length of Treatment With PegIntron/Rebetol

Time frame: After start of treatment. Mean (Standard Deviation). Unit: Weeks

Measure	PegIntron Pen/Rebetol Without Patient Assistance Program n = 478	PegIntron Pen/Rebetol With Patient Assistance Program n = 119
Value	28.8 (14.6)	27.3 (14.7)

Population analysed: Number of participants who received study drug

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PegIntron Pen/Rebetol	20 of 597 (3.4%)	100 of 597 (16.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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 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 6 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 17 May 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 Pen/Rebetol Therapy for Hepatitis C When Administered With a Patient Assistance Program (time frame: 24 or 48 weeks (depending on genotype) and 24 weeks of follow up). 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?

On the ClinicalTrials.gov record for NCT00704522.

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 6 Oct 2015.