Clinical trial NCT00689390: Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)
Official title: Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or Narlaprevir Was Administered for the Treatment of Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Hepatitis C, Chronic
Hepacivirus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 1954
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants will be followed for up to 3.5 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response (for sustained responders) and to characterize the long-term safety after use of this therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.

Detailed description: In Part 1, participants who previously participated in one of nine boceprevir studies (P03523 \[NCT00423670\], P03659 \[NCT00160251\], P04487 \[No NCT\], P05101 \[NCT00708500\], P05216 \[NCT00705432\], P05411 \[NCT00959699\], P05514 \[NCT00910624\], P05685 \[NCT00845065\], and P06086 \[NCT01023035\]) were followed for response. In Part 2, participants who previously participated in one narlaprevir study (P05104 \[NCT00797745\]) were followed for response.

Eligibility criteria: Inclusion Criteria:

* Participant must be willing to give written informed consent and be able to adhere to the visit schedule.
* Participant must have received at least one dose of boceprevir or narlaprevir in a previous Phase 1, 2, or 3 clinical study.

Exclusion Criteria:

* Concurrent participation in any other clinical study for the treatment of chronic hepatitis C.
* Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the SPRI Phase 1, 2, or 3 clinical study in which the participant previously participated.
* Any condition which in the opinion of the Investigator would make the participant unsuitable for enrollment.

Primary outcomes:
measure: Number of Participants With Relapse During the LTFU Among Sustained Responders From Previous Treatment Studies With Boceprevir or Narlaprevir (Durability of Virologic Response)
timeFrame: From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)
measure: Kaplan-Meier Exposure-adjusted Relapse Rate
timeFrame: From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)
measure: Number of Participants With HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A Protease Loci
timeFrame: From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)
measure: Number of Participants With Serious Adverse Events (SAEs) Reported During the LTFU
timeFrame: From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
measure: Number of Participants That Discontinued the LTFU Due to SAEs
timeFrame: From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Howe AY, Long J, Nickle D, Barnard R, Thompson S, Howe J, Alves K, Wahl J. Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C. Antiviral Res. 2015 Jan;113:71-8. doi: 10.1016/j.antiviral.2014.10.010. Epub 2014 Oct 24.
citation: Barnard R, Chopra A, James I, Blinco J, Watson MW, Jabara CB, Hazuda D, Lemon SM, Mallal S, Gaudieri S. Primer ID ultra-deep sequencing reveals dynamics of drug resistance-associated variants in breakthrough hepatitis C viruses: relevance to treatment outcome and resistance screening. Antivir Ther. 2016;21(7):567-577. doi: 10.3851/IMP3056. Epub 2016 May 24.