Trial Outcomes & Findings for A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response (NCT NCT01033448)
NCT ID: NCT01033448
Last Updated: 2017-10-03
Results Overview
End of treatment response rate at Week 72 was reported for genotype 1.
COMPLETED
PHASE4
59 participants
Week 72
2017-10-03
Participant Flow
Participants from Study NCT01429792 with genotype 1 Chronic Hepatitis C (CHC) and were 'Slow Responders' were eligible to enroll in this treatment extension study. Participants from Study NCT01429792 with genotype 2 and 3 CHC and were non-Rapid Virologic Response (RVR) were eligible to enroll in this treatment extension study.
A total of 59 participants were enrolled in the study and 47 of them completed the study.
Participant milestones
| Measure |
Pegylated Interferon (Peginterferon) Alfa-2a
Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
|
|---|---|
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Overall Study
STARTED
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59
|
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Overall Study
COMPLETED
|
47
|
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Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Pegylated Interferon (Peginterferon) Alfa-2a
Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Positive HCV-RNA at week 48
|
1
|
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Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrew due to other reasons
|
3
|
|
Overall Study
Unknown disposition
|
1
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Baseline Characteristics
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
Baseline characteristics by cohort
| Measure |
Pegylated Interferon (Peginterferon) Alfa-2a
n=59 Participants
Participants received pegylated interferon alfa-2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks
|
|---|---|
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Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
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34 Participants
n=5 Participants
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Sex: Female, Male
Male
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25 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Week 72Population: Participants with genotype 1 CHC at Week 72.
End of treatment response rate at Week 72 was reported for genotype 1.
Outcome measures
| Measure |
CHC Genotype 1
n=44 Participants
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
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|---|---|
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End of Treatment Response Rate at Week 72 in Genotype 1
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68.2 Percentage of Participants
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PRIMARY outcome
Timeframe: Week 48Population: Participants with CHC Genotype 2 and 3 at Week 48.
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Outcome measures
| Measure |
CHC Genotype 1
n=15 Participants
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
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|---|---|
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End of Treatment Response in Genotype 2 and 3
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66.7 Percentage of Participants
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PRIMARY outcome
Timeframe: Week 96Population: Participants with CHC genotype 1 at Week 96
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Outcome measures
| Measure |
CHC Genotype 1
n=44 Participants
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
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|---|---|
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Sustained Viral Response (SVR) Rates in CHC Genotype 1
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46.5 Percentage of participants
Interval 31.2 to 62.3
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PRIMARY outcome
Timeframe: Week 72Population: Participants with CHC Genotype 2 \& 3 at week 72.
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Outcome measures
| Measure |
CHC Genotype 1
n=15 Participants
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
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|---|---|
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SVR Rates in Genotype 2 and 3.
|
60.0 Percentage of participants
Interval 32.3 to 83.7
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SECONDARY outcome
Timeframe: Week 96Population: All enrolled participants were analyzed
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
CHC Genotype 1
n=59 Participants
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered 1000-1200 mg ribavirin were administered orally in split doses in the morning and in the evening for 24 weeks.
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|---|---|
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Percentage of Participants With Adverse Event (AE)
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40.7 Percentage of Participants
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Adverse Events
Pegylated Interferon Alfa2a (Peginterferon)
Serious adverse events
| Measure |
Pegylated Interferon Alfa2a (Peginterferon)
n=59 participants at risk
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks.
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|---|---|
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General disorders
Pyrexia
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1.7%
1/59 • Baseline to Week 96
Safety population included all enrolled participants.
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Infections and infestations
Anal Abscess
|
1.7%
1/59 • Baseline to Week 96
Safety population included all enrolled participants.
|
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Nervous system disorders
Anaesthesia
|
1.7%
1/59 • Baseline to Week 96
Safety population included all enrolled participants.
|
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Nervous system disorders
Cerebrovascular accident
|
1.7%
1/59 • Baseline to Week 96
Safety population included all enrolled participants.
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Social circumstances
Pregnancy of partner
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1.7%
1/59 • Baseline to Week 96
Safety population included all enrolled participants.
|
Other adverse events
| Measure |
Pegylated Interferon Alfa2a (Peginterferon)
n=59 participants at risk
Participants received pegylated interferon alfa2a 180 microgram (mcg) in 0.5 milliliter (mL) solution administered subcutaneous (SC) once weekly for 24 weeks. Ribavirin was administered for 24 weeks.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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20.3%
12/59 • Baseline to Week 96
Safety population included all enrolled participants.
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Blood and lymphatic system disorders
Neutropenia
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6.8%
4/59 • Baseline to Week 96
Safety population included all enrolled participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER