Trial Outcomes & Findings for Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896) (NCT NCT01340573)
NCT ID: NCT01340573
Last Updated: 2024-06-12
Results Overview
Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
TERMINATED
3 participants
Week-48
2024-06-12
Participant Flow
Participant milestones
| Measure |
All Participants
Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)
Baseline characteristics by cohort
| Measure |
All Participants
n=3 Participants
Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Indonesia
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week-48Population: The study was terminated early due to low enrollment. This analysis was not performed.
Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week-24 follow-upPopulation: The study was terminated early due to low enrollment. This analysis was not performed.
Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week-24Population: The study was terminated early due to low enrollment. This analysis was not performed.
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week-24 follow-upPopulation: The study was terminated early due to low enrollment. This analysis was not performed.
Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week-24Population: The study was terminated early due to low enrollment. This analysis was not performed.
Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week-24 follow-upPopulation: The study was terminated early due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week-48Population: The study was terminated early due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week-24 follow-upPopulation: The study was terminated early due to low enrollment. This analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: The study was terminated early due to low enrollment. This analysis was not performed.
Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER