Hepatitis C, ChronicNCT00724373

Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)

An observational study of Hepatitis C, Chronic, 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
What is being tested?: Peginterferon alfa-2b (SCH 54031) and Ribavirin (SCH 18908)
How many people: 442 participants
Where: No sites listed yet
Study dates: Nov 2007to Feb 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: Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months at sites in the UK.

Who may be able to join

Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into:
Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates.
Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).

Who cannot join

Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing.
Co-infected HCV participants (eg, human immunodeficiency virus [HIV] or hepatitis B virus [HBV]).
Participants who received their first HCV treatment in relation to a clinical trial.

About this study

Official title: Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol

The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups of Hepatitis C Virus (HCV) genotype 1 participants in the 'real world', including the relation between subgroup characteristics and treatment responsiveness.

Read the detailed description

Physicians will record information (from the time of first exposure to pegylated interferon alfa-2b and ribavirin) from the medical notes of participants who fit the inclusion criteria. To prevent selection bias, data are to be taken from the latest consecutive, unique participants seen by the physician over the previous 48 months. This provides a method of random sampling from a physician practice.

Conditions: Hepatitis C, Chronic
Being tested: Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)
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, ViraferonPeg
Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.
Ribavirin (SCH 18908)Drug
Also called Rebetol
Peginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.

Study groups in NCT00724373
Study group	Role	What they receive
Participants with genotype 1 Hepatitis C Virus infection.		Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months Receives: Biological: Peginterferon alfa-2b (SCH 54031); Drug: Ribavirin (SCH 18908)

What is being measured

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

Participants With Treatment Success
Identify subgroups of genotype 1 participants to better understand factors affecting response rates \& treatment outcomes \& to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, \& drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).
Measured: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.

Timeline

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

Nov 2007Feb 2009

First posted29 Jul 2008 (estimated)
Study startNov 2007
Primary completionFeb 2009
Study completionFeb 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: Retrospective
Enrolment: 442 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00724373
Sponsor's protocol ID: P05269
Status last verified: Sep 2015
First submitted: 25 Jul 2008
Last updated: 25 Sep 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
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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 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective Data Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol
ClinicalTrials.gov ID: NCT00724373
Acronym / sponsor ID: P05269
Conditions: Hepatitis C, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 442 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 29 Jul 2008 (estimated)
Results: Posted 7 Jun 2010

Clinical summary

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Participants with genotype 1 Hepatitis C Virus infection.	–	Biological: Peginterferon alfa-2b (SCH 54031), Drug: Ribavirin (SCH 18908)Participants with genotype 1 Hepatitis C Virus (HCV) infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months at sites in the UK.

Key inclusion criteria (3 listed)

Participants with genotype 1 HCV infection who have been treated with pegylated interferon alfa-2b and ribavirin in the preceding 48 months will be included. They will be divided into:
Completer participants: Patients with a diagnosis of HCV genotype 1 who have completed a course of interferon alfa-2b and ribavirin, with no prior treatment for HCV (ie, previously treatment naïve). Completer participants must have at least 24 weeks of follow up data available post completion of treatment to ensure ability to assess SVR rates.
Early terminators: Participants who have terminated treatment early due to adverse events or other reasons (ie, exposure is incomplete).

Key exclusion criteria (3 listed)

Participants currently undergoing therapy and therefore have not terminated treatment, ie, exposure is still ongoing.
Co-infected HCV participants (eg, human immunodeficiency virus [HIV] or hepatitis B virus [HBV]).
Participants who received their first HCV treatment in relation to a clinical trial.

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, ViraferonPegPeginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.	Biological	Participants with genotype 1 Hepatitis C Virus infection.
Ribavirin (SCH 18908)Also: RebetolPeginterferon alfa-2b plus ribavirin will be administered according to the products' labeling.	Drug	Participants with genotype 1 Hepatitis C Virus infection.

Primary outcome

Participants With Treatment Success
Time frame: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.
Identify subgroups of genotype 1 participants to better understand factors affecting response rates \& treatment outcomes \& to provide predictive models of refractory or responsive phenotypes to aid in HCV treatment, management, \& drug development. Treatment success is defined as those who had achieved sustained virological response (i.e. undetectable viraemia 24 weeks post therapy completion).

Results and safety

Results posted to the registry on 7 Jun 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
Participants With Genotype 1 Hepatitis C Virus Infection.	442	271

Primary outcome: Participants With Treatment Success

Time frame: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.. Number. Unit: Participants

Measure	Participants With Genotype 1 Hepatitis C Virus Infection. n = 243
Genotype 1a	117
Genotype 1b	63
Genotype 1a and 1b	4
Genotype 1c	0
Genotype 1 subgroup unspecified	59

Population analysed: Number of participants who had treatment success.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pegylated Interferon Alfa-2b and Ribavirin	17 of 442 (3.8%)	0 of 442 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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, 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 3 inclusion and 3 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 25 Sep 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 7 Jun 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?

Participants With Treatment Success (time frame: Data will be collected from the start of first exposure to pegylated interferon alfa-2b and ribavirin combination therapy. Participants who have successfully completed treatment will have data collected for a follow-up period of at least 24 weeks.). 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 NCT00724373.

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 25 Sep 2015.