Trial Outcomes & Findings for Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793) (NCT NCT00709228)
NCT ID: NCT00709228
Last Updated: 2015-01-26
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
496 participants
Primary outcome timeframe
Week 24 of follow-up
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
PegIntron Plus Rebetol
Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
|
|---|---|
|
Overall Study
STARTED
|
496
|
|
Overall Study
COMPLETED
|
164
|
|
Overall Study
NOT COMPLETED
|
332
|
Reasons for withdrawal
| Measure |
PegIntron Plus Rebetol
Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
|
|---|---|
|
Overall Study
Not treated
|
14
|
|
Overall Study
Eligibility criteria not met
|
281
|
|
Overall Study
Adverse events
|
2
|
|
Overall Study
Discontinued treatment
|
14
|
|
Overall Study
Did not enter follow-up
|
4
|
|
Overall Study
Discontinued follow-up
|
5
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Non-compliance
|
5
|
Baseline Characteristics
Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)
Baseline characteristics by cohort
| Measure |
PegIntron Plus Rebetol
n=170 Participants
Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative HCV-RNA at Week 4 and at Week 24 (n = 170)
|
|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24 of follow-upPopulation: The 165 participants analyzed is from the efficacy evaluable population (170) minus 5 subjects who did not have follow-up data.
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.
Outcome measures
| Measure |
PegIntron Plus Rebetol
n=165 Participants
Those with chronic Hepatitis C infected with Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) and treated withPeg-Intron 1.5 μg/kg/week plus Rebetol (ribavirin) 800-1200 mg/day who achieved a negative Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) at Week 4 and at Week 24
|
|---|---|
|
Number of HCV LVL G1 Participants Who Relapsed
|
16 Participants
|
Adverse Events
PegInton Plus Rebetol
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegInton Plus Rebetol
n=482 participants at risk
|
|---|---|
|
Cardiac disorders
PERICARDITIS
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Infections and infestations
ABSCESS NECK
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Psychiatric disorders
AGGRESSION
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Psychiatric disorders
PERSONALITY DISORDER
|
0.21%
1/482 • Number of events 2
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
|
Vascular disorders
THROMBOSIS
|
0.21%
1/482 • Number of events 1
Number analyzed is the number of treated participants (482 of the 496 screened).
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Lead investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. Lead investigator further agrees to provide 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, which report any results of the Study. Sponsor shall have the right to review and comment on any presentation, including editorial rights.
- Publication restrictions are in place
Restriction type: OTHER