Hepatitis C, ChronicPhase 3NCT00761735

5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)

A Phase 3 study testing Peginterferon alfa-2b and Ribavirin in people with 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 3 to 17 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Peginterferon alfa-2b and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: No sites listed yet
Study dates: Jul 2007to Jan 2013
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 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.
The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.
The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants whether sustained responders, relapsers, or nonresponders are eligible to participate.

Who cannot join

Concurrent participation in any other clinical study.
Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.
Any condition that in the opinion of the Investigator would make the participant unsuitable for enrollment.

About this study

Official title: Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C

Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug therapy will be administered during the P02538 Part 2 study. Durability of virologic response will be assessed for participants who attained sustained virologic response (SVR) in Part I of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In addition, this study will characterize long-term safety in all participants who received PEG-IFN plus RBV treatment.

Read the detailed description

During the Part 2 LTFU, participants will be evaluated at Years 1, 2, 3, 4, and 5. Each participant's first LTFU visit will be scheduled approximately 1 year after the post-treatment Follow-up Week 24 visit in Part 1 of this study (NCT00104052).

Conditions: Hepatitis C, Chronic
Being tested: Peginterferon alfa-2b, Ribavirin
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-2bBiological
Also called PEG-Intron®
In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).
RibavirinDrug
Also called REBETOL®
In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).

Study groups in NCT00761735
Study group	Role	What they receive
PEG-IFN + RBV: LTFU	Other	Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2. Receives: Biological: Peginterferon alfa-2b; Drug: Ribavirin

What is being measured

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

Number of Participants Who Relapsed At End of LTFU Year 5
Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.
Measured: Part 2 LTFU Year 5
Mean Height Percentiles of Participants Over LTFU
To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.
Measured: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)
Mean Weight Percentiles of Participants Over LTFU
To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.
Measured: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)
Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.
Measured: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)
Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.
Measured: Last assessment of the Part 2 LTFU (up to 5 years)

Timeline

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

Jul 2007Jan 2013

First posted29 Sep 2008 (estimated)
Study startJul 2007
Primary completionJan 2013
Study completionJan 2013

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 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761735
Sponsor's protocol ID: P02538: Part 2
Other IDs: 2004-000558-22, 2004
Status last verified: Mar 2017
First submitted: 5 Sep 2008
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

Wirth S, Ribes-Koninckx C, Calzado MA, Bortolotti F, Zancan L, Jara P, Shelton M, Kerkar N, Galoppo M, Pedreira A, Rodriguez-Baez N, Ciocca M, Lachaux A, Lacaille F, Lang T, Kullmer U, Huber WD, Gonzalez T, Pollack H, Alonso E, Broue P, Ramakrishna J, Neigut D, Valle-Segarra AD, Hunter B, Goodman Z, Xu CR, Zheng H, Noviello S, Sniukiene V, Brass C, Albrecht JK. High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. J Hepatol. 2010 Apr;52(4):501-7. doi: 10.1016/j.jhep.2010.01.016. Epub 2010 Feb 4.
PubMed 20189674

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 Hepatitis C, Chronic 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: Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron® Plus REBETOL® in Pediatric Patients With Chronic Hepatitis C
ClinicalTrials.gov ID: NCT00761735
Acronym / sponsor ID: P02538: Part 2
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 29 Sep 2008 (estimated)
Results: Posted 17 Dec 2013

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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PEG-IFN + RBV: LTFU	Other	Biological: Peginterferon alfa-2b, Drug: RibavirinPediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.
The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.
The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants whether sustained responders, relapsers, or nonresponders are eligible to participate.

Key exclusion criteria (3 listed)

Concurrent participation in any other clinical study.
Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.
Any condition that in the opinion of the Investigator would make the participant unsuitable for enrollment.

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-2bAlso: PEG-Intron®In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).	Biological	PEG-IFN + RBV: LTFU
RibavirinAlso: REBETOL®In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).	Drug	PEG-IFN + RBV: LTFU

Primary outcome

Number of Participants Who Relapsed At End of LTFU Year 5
Time frame: Part 2 LTFU Year 5
Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.
Mean Height Percentiles of Participants Over LTFU
Time frame: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)
To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.
Mean Weight Percentiles of Participants Over LTFU
Time frame: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)
To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.
Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU
Time frame: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years)
To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.
Mean Age at Attained Tanner Stages (Sexual Maturity) at End of LTFU (Last Observation) By Gender
Time frame: Last assessment of the Part 2 LTFU (up to 5 years)
The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.

Results and safety

Results posted to the registry on 17 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PEG-IFN + RBV: LTFU	94	80

Primary outcome: Number of Participants Who Relapsed At End of LTFU Year 5

Time frame: Part 2 LTFU Year 5. Number. Unit: participants

Measure	PEG-IFN + RBV: LTFU (All) n = 54
Value	0

Population analysed: Of 94 participants entering the P02538 Part 2 LTFU, 63 participants had achieved sustained virologic response (SVR) while in Part 1 of the study. 54 of these 63 participants completed 5 years of LTFU and were evaluated for relapse.

Primary outcome: Mean Height Percentiles of Participants Over LTFU

Time frame: Part 1 Pre-treatment Baseline, Part 2 LTFU Year 1, Part 2 LTFU Year 2, Part 2 LTFU Year 3, Part 2 LTFU Year 4, Part 2 LTFU Year 5, Last Available LTFU Visit (up to 5 years). Mean (Standard Deviation). Unit: percentile

Measure	PEG-IFN + RBV: LTFU (24 Weeks) n = 46	PEG-IFN + RBV: LTFU (48 Weeks) n = 48
Part 1 Pre-treatment Baseline	48.94 (27.38)	52.5 (29.98)
LTFU Year 1 (n=40, n=44)	49.21 (29.03)	43.37 (27.87)
LTFU Year 2 (n=39, n=39)	50.56 (29.18)	46.24 (29.19)
LTFU Year 3 (n=39, n=44)	48.05 (28.38)	46.00 (28.24)
LTFU Year 4 (n=40, n=38)	49.62 (30.87)	45.27 (29.44)
LTFU Year 5 (n=38, n=42)	47.61 (29.57)	43.51 (27.57)
Last Available LTFU Visit (n=46, n=48)	45.96 (30.45)	43.56 (27.19)

Population analysed: All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.

Primary outcome: Mean Weight Percentiles of Participants Over LTFU

Measure	PEG-IFN + RBV: LTFU (24 Weeks) n = 46	PEG-IFN + RBV: LTFU (48 Weeks) n = 48
Part 1 Pre-treatment Baseline	52.5 (26.83)	58.56 (30.56)
LTFU Year 1 (n=40, n=44)	53.62 (26.75)	56.38 (30.55)
LTFU Year 2 (n=39, n=39)	51.73 (26.89)	52.03 (30.47)
LTFU Year 3 (n=39, n=44)	53.18 (29.12)	54.26 (30.37)
LTFU Year 4 (n=40, n=38)	51.75 (28.90)	49.50 (30.37)
LTFU Year 5 (n=38, n=42)	51.16 (27.16)	53.12 (31.38)
Last Available LTFU Visit (n=46, n=48)	50.15 (28.44)	55.53 (30.67)

Population analysed: All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.

Primary outcome: Mean Body Mass Index (BMI) Percentiles of Participants Over LTFU

Measure	PEG-IFN + RBV: LTFU (24 Weeks) n = 46	PEG-IFN + RBV: LTFU (48 Weeks) n = 48
Part 1 Pre-treatment Baseline	50.4 (29.63)	59.76 (31.52)
LTFU Year 1 (n=40, n=44)	51.15 (30.27)	59.91 (31.55)
LTFU Year 2 (n=39, n=39)	48.11 (29.59)	52.89 (30.82)
LTFU Year 3 (n=39, n=44)	52.14 (31.00)	54.96 (30.89)
LTFU Year 4 (n=40, n=38)	48.44 (30.46)	48.69 (31.52)
LTFU Year 5 (n=38, n=42)	48.61 (29.72)	52.34 (31.87)
Last Available LTFU Visit (n=46, n=48)	48.79 (29.40)	55.38 (31.48)

Population analysed: All participants enrolled in the P02538 Part 2 LTFU were evaluated in this analysis.

Adverse events

Time frame: 5 years, starting after the Part 1 post-treatment Follow-up Week 24 visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PEG-IFN + RBV: LTFU	3 of 94 (3.2%)	0 of 0	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 20189674Wirth S, Ribes-Koninckx C, Calzado MA, Bortolotti F, Zancan L, Jara P, Shelton M, Kerkar N, Galoppo M, Pedreira A, Rodriguez-Baez N, Ciocca M, Lachaux A, Lacaille F, Lang T, Kullmer U, Huber WD, Gonzalez T, Pollack H, Alonso E, Broue P, Ramakrishna J, Neigut D, Valle-Segarra AD, Hunter B, Goodman Z, Xu CR, Zheng H, Noviello S, Sniukiene V, Brass C, Albrecht JK. High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. J Hepatol. 2010 Apr;52(4):501-7. doi: 10.1016/j.jhep.2010.01.016. Epub 2010 Feb 4.
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

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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 Peginterferon alfa-2b and Ribavirin in people with 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 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 17 Dec 2013). 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 Who Relapsed At End of LTFU Year 5 (time frame: Part 2 LTFU Year 5). The study lists 5 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 NCT00761735, 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.