N/A
Completed N=693
An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT02557646 ↗
Enrolled (actual)
693
Serious AEs
7.5%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin — 54.29; 60.87; 53.13; 50.00 percentage of participants — p=0.0437
Summary
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin |
54.29; 60.87; 53.13; 50.00; 68.56 | 0.0437 sig |
| SECONDARY Percentage of Participants With Virologic Response |
18.7; 32.7; 14.8; 1.8 | — |
| SECONDARY Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin |
0.00; 50.00; 66.67; 77.14; 67.15; 68.67 | 0.6859 |
| SECONDARY Percentage of Participants With SVR According to Starting Dose of Ribavirin |
0.00; 0.00; 66.67; 60.61; 43.13; 44.86 | 0.3740 |
| SECONDARY Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin |
40.00; 90.91; 68.93; 64.94; 68.42 | 0.0263 sig |
| SECONDARY Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin |
0.00; 54.84; 41.03; 48.54; 55.56 | 0.0475 sig |
| SECONDARY Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin |
67.49; 65.71; 79.49; 62.50 | — |
| SECONDARY Percentage of Participants With SVR According to Dose Reduction of Ribavirin |
70.00; 57.47; 63.16; 68.42 | — |
| SECONDARY Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism |
84.62; 65.38; 73.68 | — |
| SECONDARY Percentage of Participants With SVR According to IL-28B Polymorphism |
64.00; 39.22; 33.33 | — |
| SECONDARY Percentage of Participants With Viral Relapse or Breakthrough |
66.5; 27.3; 6.0 | — |
| SECONDARY Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin |
57.58; 39.39; 3.03; 66.67; 33.33; 0.00 | 0.1499 |
| SECONDARY Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin |
100.00; 0.00; 0.00; 80.00; 8.00; 12.00 | 0.5885 |
| SECONDARY Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin |
0.00; 100.00; 0.00; 60.71; 35.71; 3.57 | 0.0062 sig |
| SECONDARY Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin |
70.00; 23.57; 6.43; 57.47; 35.63; 6.90 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with serologically confirmed chronic hepatitis C
- Participants using and accepting a double method of contraception
Exclusion Criteria
- Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
- Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
- Participants previously treated with pegylated interferon and/or ribavirin
- Hepatitis B and Human Immunodeficiency Virus co-infections
Data sourced from ClinicalTrials.gov (NCT02557646). 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.