An observational study in Hepatitis C, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-16.
Sponsored by Merck Sharp & Dohme LLC · Observational
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 2 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Only participants who were originally treated in study P04793 and relapsed during the 24 week follow up phase were offered the chance to receive retreatment with PegIntron and ribavirin for up to an additional 48 weeks.
Exclusion Criteria:
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 ribavirin for 48 weeks.
Drug: Standard of Care PegIntron · Drug: Standard of Care Ribavirin
Commercially available PegIntron administered subcutaneously (SC) at 1.5 μg/kg weekly in accordance with the PegIntron Summary of Product Characteristics (SmPC).
Also known as: peginterferon alfa-2b, PEG2b, SCH 054031
Commercially available ribavirin administered orally at 800-1200 mg/day based on body weight in accordance with the ribavirin SmPC.
Also known as: REBETOL;, SCH 018908
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]
| Milestone | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.
| participants | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| Day 1, Study Part 2 | 0 |
| Treatment Week 12, Study Part 2 | 2 |
| Treatment Week 24, Study Part 2 | 2 |
| Treatment Week 48, Study Part 2 | 2 |
| Follow-up Week 24, Study Part 2 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care PegIntron Plus Ribavirin [Part 2] | — | 0/2 (0%) | 2/2 (100%) |
| Event | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| DepressionPsychiatric disorders | 2/2 |
| Age, Categorical(Participants) | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| Female | 0 |
| Male | 2 |
| Region of Enrollment(participants) | Standard of Care PegIntron Plus Ribavirin [Part 2] |
|---|---|
| Russian Federation | 2 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC