peginterferon alfa-2a [Pegasys]
Drug180 micrograms/week sc for 24 weeks
NCT Number: NCT00700401
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Vitória, Espírito Santo, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
180 micrograms/week sc for 24 weeks
800mg po daily for 24 weeks
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).
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.
Time frame: At Week 24
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
Time frame: At week 48
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Time frame: At Week 48
Positive predictive value is defined as participants with RVR who did not achieve SVR.
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.
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.
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.
Hoffmann-La Roche
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04943588
Blood-Borne Infections, Chronic Disease
Karachi, Pakistan
View Trial DetailsNCT05397067
Blood-Borne Infections, Chemically-Induced Disorders
Roanoke, Virginia, United States
View Trial DetailsNCT00148837
Blood-Borne Infections, Chronic Disease
Pessac, France
View Trial DetailsNCT04014179
Blood-Borne Infections, Chronic Disease
Bankstown, New South Wales, Australia
View Trial Details