Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)
This study has been terminated.
(This study was terminated due to low enrollment)
Sponsor:
Schering-Plough
Information provided by (Responsible Party):
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00686881
First received: May 27, 2008
Last updated: March 26, 2012
Last verified: March 2012
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Results First Received: February 3, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Hepatitis C, Chronic |
| Interventions: |
Biological: Peginterferon alfa-2b (PegIFN-2b) Drug: Comparator: Stronger neo minophagen C (SNMC) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| PegIFN-2b | Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. |
| SNMC | Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks. |
Participant Flow: Overall Study
| PegIFN-2b | SNMC | |
|---|---|---|
| STARTED | 127 [1] | 134 [2] |
| COMPLETED | 45 | 53 |
| NOT COMPLETED | 82 | 81 |
| Withdrawal by Subject | 11 | 18 |
| Lost to Follow-up | 0 | 1 |
| Treatment-related adverse event | 10 | 9 |
| Met discontinuation criteria | 5 | 0 |
| Onset of malignant tumor | 11 | 11 |
| Lack of Efficacy | 4 | 3 |
| Physician Decision | 1 | 0 |
| Circumstances of site | 1 | 1 |
| Did not meet protocol eligibility | 1 | 0 |
| Irregular visits | 1 | 0 |
| Study discontinuation | 35 | 32 |
| Never received study drug | 2 | 6 |
| [1] | After randomization, 2 participants withdrew consent and did not receive study drug. |
|---|---|
| [2] | After randomization, 6 participants withdrew consent and did not receive study drug. |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| PegIFN-2b | Participants receiving peginterferon alfa-2b (PegIFN-2b) at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. |
| SNMC | Participants receiving stronger neo minophagen C (SNMC) 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks. |
| Total | Total of all reporting groups |
Baseline Measures
| PegIFN-2b | SNMC | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
125 | 127 | 252 |
|
Age
[1] [units: years] Mean ± Standard Deviation |
59.8 ± 9.5 | 60.7 ± 8.9 | 60.3 ± 9.2 |
|
Gender
[1] [units: participants] |
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| Female | 60 | 65 | 125 |
| Male | 65 | 62 | 127 |
|
Region of Enrollment
[1] [units: participants] |
|||
| Japan | 125 | 127 | 252 |
| [1] | Of the 261 randomized participants, 253 received study drug; 1 of these participants in the SNMC Arm had no data available after initial treatment and is excluded from study analyses. |
|---|
Outcome Measures
| 1. Primary: | Number of Participants With Change in Metavir Fibrosis Score [ Time Frame: Baseline and discontinuation of treatment (up to 156 weeks) ] |
| 2. Secondary: | Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration [ Time Frame: Week 24 ] |
| 3. Secondary: | Number of Participants With Change in Metavir Inflammation Score [ Time Frame: Baseline and Week 48 ] |