Chronic Hepatitis CPhase 3NCT00048724

Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

A Phase 3 study testing peginterferon alfa-2b (SCH 54031) in people with Chronic Hepatitis C and Cirrhosis, 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

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis C, Cirrhosis
What is being tested?: peginterferon alfa-2b (SCH 54031)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 631 participants
Where: No sites listed yet
Study dates: Jun 2002to Apr 2008
Phase: Phase 3
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age at entry 18-65 years;
Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
Liver biopsy demonstrating cirrhosis

Who cannot join

Any other cause for liver disease other than chronic hepatitis C;
History or presence of complications of cirrhosis;
Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
Diseases or conditions that could interfere with participation in the study

About this study

Official title: PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin

Conditions: Chronic Hepatitis C, Cirrhosis
Being tested: peginterferon alfa-2b (SCH 54031)
Keywords: Hepatitis C; Cirrhosis
Medical subject headings: Hepatitis C, Chronic, Fibrosis, Hepatitis C

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
0.5 µg/kg subcutaneously once weekly for 60 months

Study groups in NCT00048724
Study group	Role	What they receive
PegIntron	Experimental	PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up Receives: Biological: peginterferon alfa-2b (SCH 54031)
Untreated Control	No intervention	Not described

What is being measured

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

Time to Observation of the First Clinical Event Experienced by a Subject
Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation
Measured: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

Secondary outcomes (1)

Time to Observation of the Disease Progression Experienced by a Subject
Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.
Measured: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

Timeline

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

Jun 2002Apr 2008

First posted8 Nov 2002 (estimated)
Study startJun 2002
Primary completionApr 2008
Study completionApr 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 631 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00048724
Sponsor's protocol ID: P02569
Status last verified: Mar 2017
First submitted: 6 Nov 2002
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. doi: 10.1053/j.gastro.2011.03.010. Epub 2011 Mar 17.
PubMed 21419770

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 Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin
ClinicalTrials.gov ID: NCT00048724
Acronym / sponsor ID: P02569
Conditions: Chronic Hepatitis C, Cirrhosis
Keywords: Hepatitis C; Cirrhosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 631 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2002
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 8 Nov 2002 (estimated)
Results: Posted 11 Jun 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PegIntron	Experimental	Biological: peginterferon alfa-2b (SCH 54031)PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
Untreated Control	No intervention	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age at entry 18-65 years;
Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
Liver biopsy demonstrating cirrhosis

Key exclusion criteria (4 listed)

Any other cause for liver disease other than chronic hepatitis C;
History or presence of complications of cirrhosis;
Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
Diseases or conditions that could interfere with participation in the study

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: PegIntron0.5 µg/kg subcutaneously once weekly for 60 months	Biological	PegIntron

Primary outcome

Time to Observation of the First Clinical Event Experienced by a Subject
Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event
Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation

1 secondary outcome

Time to Observation of the Disease Progression Experienced by a Subject
Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

Results and safety

Results posted to the registry on 11 Jun 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
PegIntron	311	195
Untreated Control	315	197

Primary outcome: Time to Observation of the First Clinical Event Experienced by a Subject

Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event. Number. Unit: Participants

Measure	PegIntron n = 311	Untreated Control n = 315
<=6 Months	3	2
>6 to 12 Months	5	5
>12 to 18 Months	4	4
>18 to 24 Months	3	7
>24 to 30 Months	7	6
>30 to 36 Months	1	6
>36 to 42 Months	0	5
>42 to 48 Months	2	0

PegIntron vs Untreated Control: Hazard Ratio (HR): 1.452 (95% CI 0.880 to 2.396), p = 0.1439, Cox Proportional Hazards Model

Population analysed: Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PegIntron	93 of 311 (29.9%)	290 of 311 (93.2%)	Not reported
Untreated Control	74 of 315 (23.5%)	260 of 315 (82.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21419770Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. doi: 10.1053/j.gastro.2011.03.010. Epub 2011 Mar 17.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Chronic Hepatitis C

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?

A Phase 3 study testing peginterferon alfa-2b (SCH 54031) in people with Chronic Hepatitis C and Cirrhosis, 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 4 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 4 Apr 2017. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 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?

Time to Observation of the First Clinical Event Experienced by a Subject (time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event). 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 NCT00048724, which also lists 1 linked publication.

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 4 Apr 2017.