This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
Unnamed facility
Graz, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Brasília, Brazil
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (\<) 50 international units per millilitre (IU/mL) measured \>=140 days after treatment end (i.e., \>= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.
Time frame: 24 weeks after end of treatment (Week 72)
Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)
Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.
Time frame: EOT (Week 48)
Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24
Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (\< 600 IU/mL) or an undetectable HCV RNA test result (\< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.
Time frame: Weeks 12 and 24
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Unnamed facility
Porto Alegre, Brazil
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Sao Jose Rio Preto, Brazil
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São Luís, Brazil
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São Paulo, Brazil
Unnamed facility
Créteil, France
Unnamed facility
Le Kremlin-Bicêtre, France
Unnamed facility
Marseille, France
...and 12 more locations