POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).
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|ClinicalTrials.gov Identifier: NCT00700401|
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : June 21, 2016
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment|
|Hepatitis C, Chronic||Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin [Copegus]|
|Study Type :||Observational|
|Actual Enrollment :||262 participants|
|Official Title:||A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Peginterferon Alfa-2a + Ribavirin||
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms/week sc for 24 weeksDrug: ribavirin [Copegus]
800mg po daily for 24 weeks
- Percentage of Participants With Sustained Virological Response at Week 48 [ Time Frame: At Week 48 ]Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
- Percentage of Participants With Rapid Virological Response at Week 4 [ Time Frame: At Week 4 ]Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
- Percentage of Participants With Virological Response at Week 24 [ Time Frame: At Week 24 ]Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
- Percentage of Participants With Virological Relapse [ Time Frame: At week 48 ]Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
- Percentage of Participants With Positive Predictive Value [ Time Frame: At Week 48 ]Positive predictive value is defined as participants with RVR who did not achieve SVR.
- Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to 48 weeks ]An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
- Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 [ Time Frame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48 ]Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
- Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 [ Time Frame: Baseline, Week 4, Week 12, Week 24 and Week 48 ]Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700401
|Brasilia, DF, Brazil, 70335900|
|Vitoria, ES, Brazil, 29043-260|
|Sao Luis, MA, Brazil, 65020560|
|Rio de Janeiro, RJ, Brazil, 20020-022|
|Porto Alegre, RS, Brazil, 90020-090|
|Porto Alegre, RS, Brazil, 90035-003|
|Campinas, SP, Brazil, 13060-803|
|Campinas, SP, Brazil, 13083-888|
|Ribeirao Preto, SP, Brazil, 14049-900|
|Santo Andre, SP, Brazil, 09060-650|
|Sao Paulo, SP, Brazil, 04040-003|
|Sorocaba, SP, Brazil, 18047-600|
|Study Director:||Clinical Trials||Hoffmann-La Roche|