Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)

An observational study of 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

To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C
What is being tested?: PegIntron and Rebetol
How many people: 496 participants
Where: No sites listed yet
Study dates: May 2006to Nov 2008
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: primary care clinic

Who may be able to join

Willingness to participate
18 years or older, either gender, any race
Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [HCV-RNA/qPCR] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
Subject considered suitable for treatment per local label
Investigator considers suitable and subject consents to be treated

Who cannot join

Does not show negative polymerase chain reaction [PCR] at week 4
Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics [SmPC]

About this study

Official title: PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24

Read the detailed description

Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

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

What participants receive

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

PegIntronDrug
Also called SCH 054031
1.5 ug/kg/week
RebetolDrug
Also called SCH 18908
800-1200 mg/day

Study groups in NCT00709228
Study group	Role	What they receive
PegIntron plus Rebetol		Those with chronic Hepatitis C infected with HCV LVL G1 Receives: Drug: PegIntron; Drug: Rebetol

What is being measured

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

Number of HCV LVL G1 Participants Who Relapsed
Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.
Measured: Week 24 of follow-up

Timeline

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

May 2006Nov 2008

First posted3 Jul 2008 (estimated)
Study startMay 2006
Primary completionNov 2008
Study completionNov 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 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: Cohort
Time perspective: Prospective
Enrolment: 496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00709228
Sponsor's protocol ID: P04793
Status last verified: Jan 2015
First submitted: 23 Jun 2008
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Craxi A, Koutsounas S, Ogurtsov P, Chemello L, Maticic M, Torras J, Diago M, Tartaglione MT, Witthoeft T, Yu X, Faruqi R, Chaudhri E, Pedicone LD, Zuckerman E. Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatitis C virus genotype 1 with low viral load who achieve rapid viral response. J Viral Hepat. 2012 Feb;19(2):e120-5. doi: 10.1111/j.1365-2893.2011.01515.x. Epub 2011 Sep 19.
PubMed 22239509

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
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

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24
ClinicalTrials.gov ID: NCT00709228
Acronym / sponsor ID: P04793
Conditions: Hepatitis C
Study type: Observational
Recruitment status: Completed
Enrolment: 496 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 3 Jul 2008 (estimated)
Results: Posted 22 Feb 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

Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

Study design

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

Arm	Type	Receives
PegIntron plus Rebetol	–	Drug: PegIntron, Drug: RebetolThose with chronic Hepatitis C infected with HCV LVL G1

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: primary care clinic

Key inclusion criteria (5 listed)

Willingness to participate
18 years or older, either gender, any race
Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [HCV-RNA/qPCR] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
Subject considered suitable for treatment per local label
Investigator considers suitable and subject consents to be treated

Key exclusion criteria (3 listed)

Does not show negative polymerase chain reaction [PCR] at week 4
Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the Summary of Product Characteristics [SmPC]

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: SCH 0540311.5 ug/kg/week	Drug	PegIntron plus Rebetol
RebetolAlso: SCH 18908800-1200 mg/day	Drug	PegIntron plus Rebetol

Primary outcome

Number of HCV LVL G1 Participants Who Relapsed
Time frame: Week 24 of follow-up
Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.

Results and safety

Results posted to the registry on 22 Feb 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
PegIntron Plus Rebetol	496	164

Primary outcome: Number of HCV LVL G1 Participants Who Relapsed

Time frame: Week 24 of follow-up. Number. Unit: Participants

Measure	PegIntron Plus Rebetol n = 165
Value	16

PegIntron Plus Rebetol: simple proportion: 0.097 (95% CI 0.06 to 0.15)

Population analysed: The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PegInton Plus Rebetol	11 of 482 (2.3%)	0 of 482 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22239509Craxi A, Koutsounas S, Ogurtsov P, Chemello L, Maticic M, Torras J, Diago M, Tartaglione MT, Witthoeft T, Yu X, Faruqi R, Chaudhri E, Pedicone LD, Zuckerman E. Peginterferon alfa-2b plus weight-based ribavirin for 24 weeks in patients with chronic hepatitis C virus genotype 1 with low viral load who achieve rapid viral response. J Viral Hepat. 2012 Feb;19(2):e120-5. doi: 10.1111/j.1365-2893.2011.01515.x. Epub 2011 Sep 19.

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, 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 5 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 26 Jan 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 22 Feb 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?

Number of HCV LVL G1 Participants Who Relapsed (time frame: Week 24 of 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 NCT00709228, 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 26 Jan 2015.