Hepatitis C
Conditions
Brief summary
The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.
Detailed description
All study activities were consistent with the EU Directive 2001/20/EC section for non-interventional studies (i.e. observational studies). Medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the participant to a particular therapeutic strategy is not decided in advance by the trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
Interventions
DRUGStandard of Care PegIntron
Commercially available PegIntron administered subcutaneously (SC) at 1.5 μg/kg weekly in accordance with the PegIntron Summary of Product Characteristics (SmPC).
DRUGStandard of Care Ribavirin
Commercially available ribavirin administered orally at 800-1200 mg/day based on body weight in accordance with the ribavirin SmPC.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willingness to participate * 18 years or older, either gender, any race * Participant has relapsed at the end of the Part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the Week 24 end-of-treatment time point) * Participant considered suitable for treatment per local label * Investigator considers suitable and participant consents to be treated
Exclusion criteria
* Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant * Participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study | From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2] | A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA. |
Participant flow
Pre-assignment details
Two participants who had relapsed at Follow-up Week 24 of study Part 1, and were enrolled in Part 2 to complete 48 weeks of retreatment.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care PegIntron Plus Ribavirin [Part 2] Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment Russian Federation | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study
A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.
Time frame: From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]
Population: Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1, Part 2 of the study, and who consented to retreatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care PegIntron Plus Ribavirin [Part 2] | Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study | Day 1, Study Part 2 | 0 participants |
| Standard of Care PegIntron Plus Ribavirin [Part 2] | Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study | Treatment Week 12, Study Part 2 | 2 participants |
| Standard of Care PegIntron Plus Ribavirin [Part 2] | Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study | Treatment Week 24, Study Part 2 | 2 participants |
| Standard of Care PegIntron Plus Ribavirin [Part 2] | Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study | Treatment Week 48, Study Part 2 | 2 participants |
| Standard of Care PegIntron Plus Ribavirin [Part 2] | Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study | Follow-up Week 24, Study Part 2 | 2 participants |