Hepatitis C@dhereNCT00704964

Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)

An observational study of Hepatitis C and Chronic 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.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Hepatitis C, Chronic Hepatitis C
What is being tested?: PegIntron and Rebetol
How many people: 746 participants
Where: No sites listed yet
Study dates: May 2005to Oct 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants with chronic hepatitis C treated in 44 non-university centers in Germany.

Who may be able to join

Participants with chronic hepatitis C.
Those participating in patient assistance programs during therapy for hepatitis C.

Who cannot join

Participants who have previously been treatment for hepatitis C (non-naïve)
Other exclusion criteria as described in local Summary of Product Characteristics (SPC).

About this study

Official title: Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol

The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved labeling. Sites will be categorized as providing high vs low level of participant management based on information about the level of participant support and management captured on the site questionnaire. Data on each participant will be collected by a physician on an electronic participant case report form (CRF) and by the participant via a questionnaire. Treatment completion rates will be analyzed based on the high vs low level of participant management.

The hypothesis is that Physicians investing more time and effort into participant management achieve higher treatment completion rates among their hepatitis C patients than physicians offering less participant management measures.

Conditions: Hepatitis C, Chronic Hepatitis C
Being tested: PegIntron, Rebetol
Medical subject headings: Hepatitis C, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegIntronBiological
Also called PegIntron pen, peginterferon alfa-2b, SCH 54031
PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany
RebetolDrug
Also called ribavirin, SCH 18908
Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany

Study groups in NCT00704964
Study group	Role	What they receive
All participants		Each site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites. Receives: Biological: PegIntron; Drug: Rebetol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Biometrical Adherence to Therapy
Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
Measured: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
Number of Participants With Adherence to Therapy According to Physician Approximation
Adherence was based on physiciant's clinical judgment.
Measured: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3

Timeline

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

May 2005Oct 2009

First posted25 Jun 2008 (estimated)
Study startMay 2005
Primary completionOct 2009
Study completionOct 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 CStudies 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: Case only
Time perspective: Prospective
Enrolment: 746 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704964
Sponsor's protocol ID: P04413
Acronym: @dhere
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

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Elimination of Hepatitis C Virus Among Users of Substances
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Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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All Hepatitis C 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: Impact of Patient Support From Medical Staff on the Adherence to Therapy With PegIntron Plus Rebetol
ClinicalTrials.gov ID: NCT00704964
Acronym / sponsor ID: @dhere / P04413
Conditions: Hepatitis C, Chronic Hepatitis C
Study type: Observational
Recruitment status: Completed
Enrolment: 746 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 25 Jun 2008 (estimated)
Results: Posted 21 Apr 2011

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: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Biological: PegIntron, Drug: RebetolEach site will be evaluated by a site questionnaire and assigned as either a high or low participant management site. Participants are not randomized to a group. However, treatment completion rates will be evaluated based on the high vs low participant management sites.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants with chronic hepatitis C treated in 44 non-university centers in Germany.

Key inclusion criteria (2 listed)

Participants with chronic hepatitis C.
Those participating in patient assistance programs during therapy for hepatitis C.

Key exclusion criteria (2 listed)

Participants who have previously been treatment for hepatitis C (non-naïve)
Other exclusion criteria as described in local Summary of Product Characteristics (SPC).

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
PegIntronAlso: PegIntron pen, peginterferon alfa-2b, SCH 54031PegIntron (peginterferon alfa-2b) pen administered at a dose and frequency in accordance with approved labeling in Germany	Biological	All participants
RebetolAlso: ribavirin, SCH 18908Rebetol (ribavirin) administered at a dose and frequency in accordance with approved labeling in Germany	Drug	All participants

Primary outcome

Number of Participants With Biometrical Adherence to Therapy
Time frame: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
Adherence was defined as participants receiving at least 80% of the planned PegIntron doses, or at least 80% of the planned Rebetol doses, or participants concluding at least 80% of the planned duration of their treatment, or all three conditions.
Number of Participants With Adherence to Therapy According to Physician Approximation
Time frame: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3
Adherence was based on physiciant's clinical judgment.

Results and safety

Results posted to the registry on 21 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	746	418

Primary outcome: Number of Participants With Biometrical Adherence to Therapy

Time frame: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3. Number. Unit: Participants

Measure	All Participants n = 746
PegIntron + Rebetol	406
PegIntron	415
Rebetol	413

Primary outcome: Number of Participants With Adherence to Therapy According to Physician Approximation

Time frame: Up to 48 weeks for HCV genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3. Number. Unit: Participants

Measure	All Participants n = 746
PegIntron	615
Rebetol	604

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	27 of 746 (3.6%)	332 of 746 (44.5%)	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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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

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 and Chronic 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 2 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 21 Apr 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 With Biometrical Adherence to Therapy (time frame: Up to 48 weeks for Hepatitis C Virus (HCV) genotype 1 or 4 participants and up to 24 weeks for HCV genotype 2 or 3). 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 NCT00704964.

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.