A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
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|ClinicalTrials.gov Identifier: NCT01447420|
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : June 24, 2016
Last Update Posted : July 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: peginterferon alfa-2a Drug: ribavirin [Copegus]||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|Experimental: Peginterferon Alfa-2a Plus Ribavirin||
Drug: peginterferon alfa-2a
180 mcg sc weekly, 48 weeksDrug: ribavirin [Copegus]
1'000 or 1'200 mg orally daily, 48 weeks
- Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression [ Time Frame: At Week 72 ]Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.
- Percentage of Participants With Incidence of Anemia [ Time Frame: Up to Week 72 ]Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.
- Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression [ Time Frame: Weeks 4, 12, 24, 48, 60 and 72 ]Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.
- Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment [ Time Frame: Up to Week 72 ]Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.
- Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12 [ Time Frame: From Baseline (Week 0) to Week 12 ]Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447420
|Salvador, BA, Brazil, 41110-170|
|Vitoria, ES, Brazil, 29043-260|
|Juiz de Fora, MG, Brazil, 36038-330|
|Rio de Janeiro, RJ, Brazil, 20020-022|
|Rio de Janeiro, RJ, Brazil, 20270-004|
|Joinville, SC, Brazil, 89202-050|
|Sao Jose Do Rio Preto, SC, Brazil, 15090-000|
|Botucatu, SP, Brazil, 18600-400|
|Campinas, SP, Brazil, 13026-210|
|Campinas, SP, Brazil, 13060-803|
|Santos, SP, Brazil, 11015470|
|Sao Paulo, SP, Brazil, 04040-003|
|Sao Paulo, SP, Brazil, 04119-001|
|Sao Paulo, SP, Brazil, 04266-010|
|Sorocaba, SP, Brazil, 18047-600|
|Study Director:||Clinical Trials||Hoffmann-La Roche|