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Clinical Trial Details

Trial ID: L1427
Source ID: NCT02864199
Associated Drug: Peginterferon Alfa-2a
Title: A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hepatitis C, Chronic
Interventions: DRUG: Peginterferon alfa-2a|DRUG: Ribavirin
Outcome Measures: Primary: Cmax of peginterferon alfa-2a, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|CL/F of ribavirin, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|Percentage of participants with undetectable HCV RNA level, Week 12|Cmax of ribavirin, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|AUC of ribavirin, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|AUC of peginterferon alfa-2a, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|Clearance (CL/F) of peginterferon alfa-2a, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12 | Secondary: Time of maximum concentration (Tmax) of peginterferon alfa-2a, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|Tmax of ribavirin, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|Plasma concentration of ribavirin, Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12|Percentage of participants with adverse events (AEs), From Baseline to Week 12 (or up to Week 48 if treatment continued)|Percentage of participants with a dose modification or premature withdrawal for safety reasons, From Baseline to Week 12 (or up to Week 48 if treatment continued)
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 63
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-02
Completion Date: 2007-09
Results First Posted:
Last Update Posted: 2016-08-11
Locations: Birmingham, Alabama, 35294, United States|Kansas City, Kansas, 66160, United States|New Orleans, Louisiana, 70112, United States|Kansas City, Missouri, 64128, United States|St Louis, Missouri, 63110, United States|New York, New York, 10029, United States|Syracuse, New York, 13210, United States|Cleveland, Ohio, 44106, United States|Portland, Oregon, 97239, United States|Pittsburgh, Pennsylvania, 15213, United States|Dallas, Texas, 75203, United States|Galveston, Texas, 77555, United States|Sao Paulo, 04038-002, Brazil|Marseille, 13285, France|Christchurch, 8011, New Zealand|Riccarton, Christchurch, 8011, New Zealand|Huddinge, 14186, Sweden
URL: https://clinicaltrials.gov/show/NCT02864199

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D230 Ribavirin small molecule DB00811 Details