N/A
Completed N=2,430
Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
Hepatitis C, Chronic · Hepatitis C
Source: ClinicalTrials.gov NCT00724893 ↗
Enrolled (actual)
2,430
Serious AEs
—
Results posted
Nov 2013
Primary outcomePrimary: Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) — 685 participants
Summary
Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) |
685 | — |
| PRIMARY Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) |
660 | — |
| PRIMARY Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) |
638 | — |
| PRIMARY Number of Participants Achieving SVR (Stage 2) |
468 | — |
| SECONDARY Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) |
76; 142 | — |
| SECONDARY Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) |
685 | — |
| SECONDARY Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) |
660 | — |
| SECONDARY Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) |
638 | — |
| SECONDARY The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) |
679 | — |
| SECONDARY The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) |
612 | — |
| SECONDARY The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) |
308; 129; 215; 6; 0; 2 | — |
| SECONDARY The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) |
34; 89; 95; 51; 40; 351 | — |
| SECONDARY Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) |
33; 85; 90; 49; 38; 343 | — |
| SECONDARY Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) |
298; 126; 207; 5; 0; 2 | — |
| SECONDARY Number of Participants Achieving SVR by Viral Load (Stage 1) |
353; 63; 222 | — |
| SECONDARY Number of Participants Achieving SVR by Weight (Stage 1) |
10; 82; 158; 137; 251 | — |
| SECONDARY Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) |
21; 55; 64; 28; 25; 105 | — |
| SECONDARY Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) |
222; 42; 34; 53; 4; 69 | — |
| SECONDARY Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) |
4; 39; 76; 61; 118; 5 | — |
| SECONDARY Number of Participants Achieving EVR (Stage 1) |
473 | — |
| SECONDARY Number of Participants Achieving SVR by EVR Type (Stage 1) |
15; 253; 2 | — |
| SECONDARY Number of Participants Achieving SVR by Gender (Stage 1) |
241; 397 | — |
| SECONDARY Number of Participants Achieving SVR by Race (Stage 1) |
59; 9; 524; 4; 42 | — |
| SECONDARY Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) |
3; 543; 92 | — |
| SECONDARY Number of Participants With End of Treatment (EOT) Response (Stage 1) |
800 | — |
| SECONDARY Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) |
405; 395; 0 | — |
| SECONDARY Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) |
461; 473 | — |
| SECONDARY Relapse Rate by HCV Genotype (Stage 1) |
11.5; 3.2; 9.7; 40.0; 0 | — |
| SECONDARY Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) |
52; 24 | — |
| SECONDARY Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2) |
56 | — |
| SECONDARY Number of Participants Achieving EVR (Stage 2) |
690 | — |
| SECONDARY Number of Participants Achieving RVR by Race (Stage 2) |
0; 6; 0; 47; 0; 3 | — |
| SECONDARY Number of Participants Achieving EVR by Race (Stage 2) |
6; 42; 8; 609; 4; 21 | — |
| SECONDARY Number of Participants Achieving SVR by Race (Stage 2) |
4; 37; 5; 407; 4; 11 | — |
| SECONDARY Number of Participants Achieving RVR Who Achieved SVR (Stage 2) |
35 | — |
| SECONDARY Number of Participants Achieving EVR Who Achieved SVR (Stage 2) |
399 | — |
| SECONDARY Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) |
4; 9; 8; 2; 1; 29 | — |
| SECONDARY Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) |
49; 95; 133; 62; 53; 280 | — |
| SECONDARY Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) |
36; 72; 94; 35; 35; 187 | — |
| SECONDARY Number of Participants Achieving RVR by Weight (Stage 2) |
0; 8; 9; 11; 27; 1 | — |
| SECONDARY Number of Participants Achieving EVR by Weight (Stage 2) |
9; 87; 164; 143; 283; 4 | — |
| SECONDARY Number of Participants Achieving SVR by Weight (Stage 2) |
6; 59; 115; 93; 193; 2 | — |
| SECONDARY Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) |
17; 9; 26; 1; 3 | — |
| SECONDARY Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) |
106; 51; 518; 8; 7 | — |
| SECONDARY Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) |
58; 37; 364; 5; 4 | — |
| SECONDARY Number of Participants Achieving RVR by Gender (Stage 2) |
19; 37 | — |
| SECONDARY Number of Participants Achieving EVR by Gender (Stage 2) |
227; 463 | — |
| SECONDARY Number of Participants Achieving SVR by Gender (Stage 2) |
167; 301 | — |
| SECONDARY Number of Participants Achieving RVR by HIV Status (Stage 2) |
— | — |
| SECONDARY Number of Participants Achieving EVR by HIV Status (Stage 2) |
— | — |
| SECONDARY Number of Participants Achieving SVR by HIV Status (Stage 2) |
— | — |
| SECONDARY Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) |
40.0; 39.1 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve patients with chronic hepatitis C
- Adults (>18 years of age)
- Prescribed Pegetron Redipen
- Must meet all requirements for treatment with Pegetron Redipen
- Must be able to obtain reimbursement of medication through private or provincial coverage
Exclusion Criteria
- Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
- HIV antibody positive
- Post liver transplant patients
- Any other exclusion criteria as per the product Monograph
Data sourced from ClinicalTrials.gov (NCT00724893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.