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

Hepatitis C, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761735
• Other study ID #: P02538: Part 2
• Secondary ID: 2004-000558-22
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2008
• Last updated: September 11, 2015
• Start date: July 2007
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Biological:
• Peginterferon alfa-2b
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).

Drug:
• Ribavirin
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Part 2 LTFU Year 5	No
Primary	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.	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)	Yes
Primary	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.	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)	Yes
Primary	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.	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)	Yes
Primary	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.	Last assessment of the Part 2 LTFU (up to 5 years)	Yes