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 2015-01-26.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Observational
To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 496 is above the median of 245 across 574 observational studies indexed under Hepatitis C.
Browse Hepatitis C studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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primary care clinic
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Exclusion Criteria:
Those with chronic Hepatitis C infected with HCV LVL G1
Drug: PegIntron · Drug: Rebetol
Number of HCV LVL G1 Participants Who Relapsed
Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.
Time frame: Week 24 of follow-up
| Milestone | PegIntron Plus Rebetol |
|---|---|
| Started | 496 |
| Completed | 164 |
| Not completed | 332 |
| Withdrew: Not treated | 14 |
| Withdrew: Eligibility criteria not met | 281 |
| Withdrew: Adverse events | 2 |
| Withdrew: Discontinued treatment | 14 |
| Withdrew: Did not enter follow-up | 4 |
| Withdrew: Discontinued follow-up | 5 |
| Withdrew: Disease progression | 1 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Non-compliance | 5 |
Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.
| Participants | PegIntron Plus Rebetol |
|---|---|
| Number of HCV LVL G1 Participants Who Relapsed | 16 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PegInton Plus Rebetol | — | 11/482 (2.3%) | 0/482 (0%) |
| Event | PegInton Plus Rebetol |
|---|---|
| PERICARDITISCardiac disorders | 1/482 |
| VERTIGOEar and labyrinth disorders | 1/482 |
| HYPOTHYROIDISMEndocrine disorders | 1/482 |
| PANCREATITISGastrointestinal disorders | 1/482 |
| ABSCESS NECKInfections and infestations | 1/482 |
| MULTIPLE INJURIESInjury, poisoning and procedural complications | 1/482 |
| ACUTE PSYCHOSISPsychiatric disorders | 1/482 |
| AGGRESSIONPsychiatric disorders | 1/482 |
| PERSONALITY DISORDERPsychiatric disorders | 1/482 |
| SUICIDE ATTEMPTPsychiatric disorders | 1/482 |
| Age, Continuous(years) | PegIntron Plus Rebetol |
|---|---|
| Mean | 37.8 ± 10.4 |
| Sex: Female, Male(Participants) | PegIntron Plus Rebetol |
|---|---|
| Female | 68 |
| Male | 102 |
No study locations are listed for this record.
The record gives a start of May 2006, a primary completion of Nov 2008 and a completion of Nov 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2010, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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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