HepatitisPhase 3NCT00039871

PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

A Phase 3 study testing PegIntron (peginterferon alfa-2b; SCH 54031) and REBETOL (ribavirin; SCH 18908) in people with Hepatitis and 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 to 65 years
Conditions the study is for: Hepatitis, Hepatitis C, Chronic, Fibrosis
What is being tested?: PegIntron (peginterferon alfa-2b; SCH 54031) and REBETOL (ribavirin; SCH 18908)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,333 participants
Where: No sites listed yet
Study dates: May 2002to Sep 2007
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
Positive for Hepatitis C
Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Who cannot join

Any cause for the liver disease other than chronic hepatitis C
History or presence of complications of cirrhosis
Alcohol or illicit drug use or methadone treatment within the past 2 years
Treatment for chronic hepatitis C within the previous 6 months
Diseases or conditions that could interfere with the subject's participation in and completion of the study

About this study

Official title: PEG-Intron Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).

Conditions: Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis
Being tested: PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908)
Medical subject headings: Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis

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 SCH 54031
PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks
REBETOL (ribavirin; SCH 18908)Drug
REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks

Study groups in NCT00039871
Study group	Role	What they receive
Overall study population	Experimental	Not described 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.

Sustained Virologic Response (SVR) Rate
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)
Measured: Assessed at end of 24 weeks posttreatment follow-up

Secondary outcomes (2)

Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Measured: 24 weeks posttreatment
Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up
Measured: 24 weeks posttreatment

Timeline

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

May 2002Sep 2007

First posted14 Jun 2002 (estimated)
Study startMay 2002
Primary completionSep 2007
Study completionSep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HepatitisStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00039871
Sponsor's protocol ID: P02370
Status last verified: Mar 2017
First submitted: 13 Jun 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

Poynard T, Munteanu M, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, Moreno-Otero R, Carrilho F, Schmidt W, Berg T, McGarrity T, Heathcote EJ, Goncales F, Diago M, Craxi A, Silva M, Boparai N, Griffel L, Burroughs M, Brass C, Albrecht J. FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC(3) program. J Hepatol. 2011 Feb;54(2):227-35. doi: 10.1016/j.jhep.2010.06.038. Epub 2010 Sep 15.
PubMed 21056496

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
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users

All Hepatitis 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 Plus REBETOL for the Treatment of Subjects With Chronic Hepatitis C Who Failed to Respond to Previous Combination Therapy (Any Alpha Interferon Treatment in Combination With Ribavirin)
ClinicalTrials.gov ID: NCT00039871
Acronym / sponsor ID: P02370
Conditions: Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,333 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2002
Primary completion: Sep 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 14 Jun 2002 (estimated)
Results: Posted 11 Dec 2008

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Overall study population	Experimental	Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: REBETOL (ribavirin; SCH 18908)

Who may qualify

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

Key inclusion criteria (4 listed)

Age at entry 18-65
Positive for Hepatitis C
Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Key exclusion criteria (5 listed)

Any cause for the liver disease other than chronic hepatitis C
History or presence of complications of cirrhosis
Alcohol or illicit drug use or methadone treatment within the past 2 years
Treatment for chronic hepatitis C within the previous 6 months
Diseases or conditions that could interfere with the subject's participation in and completion of 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
PegIntron (peginterferon alfa-2b; SCH 54031)Also: SCH 54031PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks	Biological	Overall study population
REBETOL (ribavirin; SCH 18908)REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks	Drug	Overall study population

Primary outcome

Sustained Virologic Response (SVR) Rate
Time frame: Assessed at end of 24 weeks posttreatment follow-up
Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)

2 secondary outcomes

Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12
Time frame: 24 weeks posttreatment
Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12
Time frame: 24 weeks posttreatment

Results and safety

Results posted to the registry on 11 Dec 2008, 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 Plus Rebetol	2,312	928

Primary outcome: Sustained Virologic Response (SVR) Rate

Time frame: Assessed at end of 24 weeks posttreatment follow-up. Number. Unit: Participants

Measure	PegIntron Plus Rebetol n = 2293
Value	497

PegIntron Plus Rebetol: Binomial Approximation: 0.217 (99% CI 0.195 to 0.239)

Population analysed: Participants who received at least one dose of study medication

2 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
PegIntron Plus Rebetol	200 of 2,312 (8.7%)	2,201 of 2,312 (95.2%)	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.
Results publication: PubMed 21056496Poynard T, Munteanu M, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, Moreno-Otero R, Carrilho F, Schmidt W, Berg T, McGarrity T, Heathcote EJ, Goncales F, Diago M, Craxi A, Silva M, Boparai N, Griffel L, Burroughs M, Brass C, Albrecht J. FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC(3) program. J Hepatol. 2011 Feb;54(2):227-35. doi: 10.1016/j.jhep.2010.06.038. Epub 2010 Sep 15.
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 Hepatitis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
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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 PegIntron (peginterferon alfa-2b; SCH 54031) and REBETOL (ribavirin; SCH 18908) in people with Hepatitis and 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 4 inclusion and 5 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 Dec 2008). 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?

Sustained Virologic Response (SVR) Rate (time frame: Assessed at end of 24 weeks posttreatment follow-up). 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 NCT00039871, 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.