Trial Outcomes & Findings for Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261) (NCT NCT00726557)

NCT ID: NCT00726557

Last Updated: 2015-10-09

Results Overview

Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).

• Recruitment status: COMPLETED
• Target enrollment: 246 participants
• Primary outcome timeframe: End of Follow-up (Week 48 or Week 72, depending on genotype)
• Results posted on: 2015-10-09

Participant Flow

Participant milestones

Measure	PegIntron + Rebetol PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
Overall Study STARTED	246
Overall Study COMPLETED	118
Overall Study NOT COMPLETED	128

Reasons for withdrawal

Measure	PegIntron + Rebetol PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
Overall Study Screening failure	4
Overall Study No end of treatment documentation	37
Overall Study No follow-up documentation available	55
Overall Study Treatment less than 3 months	17
Overall Study Inclusion criteria not met	15

Baseline Characteristics

Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)

Baseline characteristics by cohort

Measure	PegIntron + Rebetol n=246 Participants Baseline measures only available for the 118 participants who completed.
Age, Continuous	36.64 years STANDARD_DEVIATION 8.39 • n=5 Participants
Sex/Gender, Customized Female	35 participants n=5 Participants
Sex/Gender, Customized Male	83 participants n=5 Participants
Sex/Gender, Customized Unavailable	128 participants n=5 Participants
Region of Enrollment Germany	246 participants n=5 Participants

PRIMARY outcome

Timeframe: End of Follow-up (Week 48 or Week 72, depending on genotype)

Population: Participants who achieved SVR at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4)

Participants who achieved SVR (sustained virological response) at the end of treatment (24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4) were analyzed for sustained response at the end of the follow-up period (24 weeks after end of treatment). SVR is defined as having negative HCV-RNA (hepatitis C virus ribonucleic acid).

Outcome measures

Measure	Participants With Negative HCV-RNA at End of Treatment n=101 Participants End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions Opioid substitution with methadone (n=52)	49 Participants
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions Opioid substitution with levo-methadone (n=13)	10 Participants
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions Opioid substitution with buprenorphine (n=26)	23 Participants
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions Opioid substitution with other medication (n=1)	0 Participants
Number of Drug-substituted Participants Who Achieved Sustained Virological Response (SVR) With PegIntron 1.5 μg/kg/Week and Rebetol (10.6 mg/kg/Day) in Substitution Centers Under Routine Conditions No opioid substitution medication (n=9)	9 Participants

PRIMARY outcome

Timeframe: Assessed at the end of treatment

Population: All enrolled participants

Tolerability of the treatment was measured by number of participants with complete treatment.

Outcome measures

Measure	Participants With Negative HCV-RNA at End of Treatment n=246 Participants End of treatment is 24 weeks for genotypes 2,3 and 48 weeks for genotypes 1,4
Number of Participants Who Tolerated Treatment With PegIntron 1.5 mcg/kg/Week + Rebetol 10.6 mg/kg/Week	118 participants

Adverse Events

PegIntron + Rebetol

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PegIntron + Rebetol n=246 participants at risk PegIntron 1.5 mcg/kg/week + Rebetol 10.6 mg/kg/day administered for a minimum of 12 weeks. Participants who achieved early virological response at Treatment Week 12 continued to receive therapy for a total of 24 or 48 weeks, depending on genotype.
Infections and infestations Endocarditis	0.41% 1/246 • Number of events 1 Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.
Infections and infestations Pneumonia	0.41% 1/246 • Number of events 1 Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.
Metabolism and nutrition disorders Diabetes mellitus	0.41% 1/246 • Number of events 1 Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.
Nervous system disorders Convulsion	0.41% 1/246 • Number of events 1 Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.
Social circumstances Pregnancy of partner	0.41% 1/246 • Number of events 1 Non-serious adverse events (AEs) were not captured as part of the study database. Nevertheless, at the end of each visit, physicians were asked to state if an AE occurred since the last visit. Therefore, it is possible to show only the total number of AEs, which was 104 in the 118 complete participants and 224 in all 246 enrolled participants.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Trial results belong to the Sponsor only, all investigators are not allowed to publish trial results without permission of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER