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Clinical Trial Details

Trial ID: L1218
Source ID: NCT02806505
Associated Drug: Peginterferon Alfa-2a
Title: HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02806505/results
Conditions: Hepatitis C, Chronic
Interventions: DRUG: Peginterferon alfa-2a
Outcome Measures: Primary: 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., 24 weeks after end of treatment (Week 72) | Secondary: 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., 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., Weeks 12 and 24
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 81
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-06
Completion Date: 2007-08
Results First Posted: 2016-10-31
Last Update Posted: 2016-10-31
Locations: Graz, 8036, Austria|Wien, 1090, Austria|Brasilia, 70335-000, Brazil|Porto Alegre, 90035-003, Brazil|Sao Jose Rio Preto, 15090-003, Brazil|Sao Luis, 78048-790, Brazil|Sao Paulo, 04023-900, Brazil|Creteil, 94010, France|Le Kremlin-bicetre, 94275, France|Marseille, 13385, France|Paris, 75747, France|Strasbourg, 67091, France|Toulouse, 31059, France|Athens, 11527, Greece|Nikea, 18354, Greece|Medan, 20119, Indonesia|Cagliari, 09134, Italy|Istanbul, 34303, Turkey|Istanbul, 34390, Turkey|Istanbul, 34662, Turkey|Izmir, 35040, Turkey|Abu Dhabi, United Arab Emirates
URL: https://clinicaltrials.gov/show/NCT02806505