Hepatitis C, ChronicNCT00728494

Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

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

Completed

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

Trial summary

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label. 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; SCH 54031), Rebetol (ribavirin; SCH 18908) and Patient Assistance Program
Type of treatment: Lifestyle or therapy programme
How many people: 99 participants
Where: No sites listed yet
Study dates: Oct 2005to Dec 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with chronic HCV.

Who may be able to join

According to PegIntron/Rebetol label.
Only HCV genotype 1 infected patients will be enrolled in the study.

Who cannot join

According to PegIntron/Rebetol label.

About this study

Official title: Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Read the detailed description

Non-Probability Sample, Commercial product used according to EU label.

Conditions: Hepatitis C, Chronic, Hepatitis C
Being tested: PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908), Patient Assistance Program
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; SCH 54031)Biological
Also called PegIntron
Peginterferon alfa-2b will be administered according to the product's labeling.
Rebetol (ribavirin; SCH 18908)Drug
Also called Rebetol
Ribavirin will be administered according to the product's labeling.
Patient Assistance ProgramBehavioural
Also called Support program
The patient assistance program includes the following:
- Training by physicians or specialized nurses.
- Informational materials based on the "To beat HCV" program.
- Management of specific side effects.

Study groups in NCT00728494
Study group	Role	What they receive
Treatment and Patient Assistance Program		Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events. Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908); Behavioral: Patient Assistance Program
Treatment Alone		PegIntron/Rebetol treatment only. Receives: Biological: PegIntron (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.

The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
Measured: At the end of the 48-week treatment period
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
Measured: Measured at 6 months post-treatment
The Number of Participants Who Relapsed at 6 Months Post-treatment
Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment
Measured: Measured at end of treatment and 6 months post-treatment

Secondary outcomes (3)

Average Length of Treatment
Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.
Measured: Maximum 48-week treatment duration
Average Dosage of PegIntron
Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week
Measured: Up to 48-week treatment duration
Average Dosage of Rebetol
Rebetol dosage was expressed in milligrams per kilogram of body weight per day.
Measured: Up to 48-week treatment duration

Timeline

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

Oct 2005Dec 2007

First posted5 Aug 2008 (estimated)
Study startOct 2005
Primary completionDec 2007
Study completionDec 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: Cohort
Time perspective: Prospective
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00728494
Sponsor's protocol ID: P04671
Status last verified: Jul 2015
First submitted: 31 Jul 2008
Last updated: 28 Jul 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 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.
ClinicalTrials.gov ID: NCT00728494
Acronym / sponsor ID: P04671
Conditions: Hepatitis C, Chronic, Hepatitis C
Study type: Observational
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 5 Aug 2008 (estimated)
Results: Posted 19 Aug 2009

Clinical summary

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

Detailed description

Non-Probability Sample, Commercial product used according to EU label.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Treatment and Patient Assistance Program	–	Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908), Behavioral: Patient Assistance ProgramPatient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.
Treatment Alone	–	Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)PegIntron/Rebetol treatment only.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic HCV.

Key inclusion criteria (2 listed)

According to PegIntron/Rebetol label.
Only HCV genotype 1 infected patients will be enrolled in the study.

Key exclusion criteria (1 listed)

According to PegIntron/Rebetol 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; SCH 54031)Also: PegIntronPeginterferon alfa-2b will be administered according to the product's labeling.	Biological	Treatment Alone, Treatment and Patient Assistance Program
Rebetol (ribavirin; SCH 18908)Also: RebetolRibavirin will be administered according to the product's labeling.	Drug	Treatment Alone, Treatment and Patient Assistance Program
Patient Assistance ProgramAlso: Support programThe patient assistance program includes the following: * Training by physicians or specialized nurses. * Informational materials based on the "To beat HCV" program. * Management of specific side effects.	Behavioural	Treatment and Patient Assistance Program

Primary outcome

The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
Time frame: At the end of the 48-week treatment period
Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program
The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
Time frame: Measured at 6 months post-treatment
Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment
The Number of Participants Who Relapsed at 6 Months Post-treatment
Time frame: Measured at end of treatment and 6 months post-treatment
Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment

3 secondary outcomes

Average Length of Treatment
Time frame: Maximum 48-week treatment duration
Average Dosage of PegIntron
Time frame: Up to 48-week treatment duration
Average Dosage of Rebetol
Time frame: Up to 48-week treatment duration

Results and safety

Results posted to the registry on 19 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment and Patient Assistance Program	60	51
Treatment Alone	39	32

Primary outcome: The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C

Time frame: At the end of the 48-week treatment period. Number. Unit: Participants

Measure	Treatment and Patient Assistance Program n = 60	Treatment Alone n = 39
Value	51	32

Primary outcome: The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment

Time frame: Measured at 6 months post-treatment. Number. Unit: Participants

Measure	Treatment and Patient Assistance Program n = 51	Treatment Alone n = 12
Value	29	7

Primary outcome: The Number of Participants Who Relapsed at 6 Months Post-treatment

Time frame: Measured at end of treatment and 6 months post-treatment. Number. Unit: Participants

Measure	Treatment and Patient Assistance Program n = 51	Treatment Alone n = 12
Value	17	4

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment and Patient Assistance Program	0 of 60 (0%)	39 of 60 (65%)	Not reported
Treatment Alone	0 of 39 (0%)	28 of 39 (71.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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 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 2 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 28 Jul 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 19 Aug 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?

The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C (time frame: At the end of the 48-week treatment period). The study lists 3 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 NCT00728494.

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 28 Jul 2015.