Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Hepatitis C, Chronic; Hepacivirus

Treatments: Drug: Ribavirin; Biological: Boceprevir; Biological: Narlaprevir; Biological: Peginterferon alfa-2b; Other: Blood/Plasma Collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689390

2006-006529-25 (EudraCT Number)

P05063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,954 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,954 participants in 2 patient groups

Participants from Boceprevir Studies

Other group

Description:

Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.

Treatment:

Biological: Peginterferon alfa-2b

Biological: Boceprevir

Other: Blood/Plasma Collection

Drug: Ribavirin

Participants from Narlaprevir Studies

Other group

Description:

Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.

Treatment:

Biological: Peginterferon alfa-2b

Biological: Narlaprevir

Other: Blood/Plasma Collection

Drug: Ribavirin