Trial Outcomes & Findings for Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2) (NCT NCT01054742)
NCT ID: NCT01054742
Last Updated: 2015-01-16
Results Overview
A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.
Recruitment status
COMPLETED
Target enrollment
2 participants
Primary outcome timeframe
From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2]
Results posted on
2015-01-16
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)
Baseline characteristics by cohort
| Measure |
Standard of Care PegIntron Plus Ribavirin [Part 2]
n=2 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.
Outcome measures
| Measure |
Standard of Care PegIntron Plus Ribavirin [Part 2]
n=2 Participants
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.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Standard of Care PegIntron Plus Ribavirin [Part 2]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care PegIntron Plus Ribavirin [Part 2]
n=2 participants at risk
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.
|
|---|---|
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Psychiatric disorders
Depression
|
100.0%
2/2 • Number of events 2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees to provide forty-five (45) days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review copies of abstracts or manuscripts for publication (including, without limitation, slides and text of oral or other public presentations and text of any transmission through any electronic media), which report any results of the Study. The sponsor shall have the right to review and comment on any presentation including editorial rights.
- Publication restrictions are in place
Restriction type: OTHER