CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Peginterferon alfa-2a with Ribavirin +1 moredrug
Likely dose
Peginterferon alfa-2a 180 μg subcutaneous once weekly + weight-based ribavirin (1000 mg daily for <75 kg, 1200 mg daily for ≥75 kg) for 48 weeksAI-extracted
Key inclusion· 7
  • ✓Age 18 years or older
  • ✓Detectable HCV RNA in serum
  • ✓Genotype 1 HCV infection confirmed by probe-specific hybridization
  • ✓Chronic hepatitis confirmed on liver biopsy within past 48 months with necroinflammatory activity index ≥3/18
Key exclusion· 14
  • ✕Prior treatment with alpha interferon
  • ✕If cirrhosis present: decompensated disease (bilirubin >4 mg%, albumin <3.0 g%, PT >2 sec prolonged, or history of variceal bleeding, ascites, hepatic encephalopathy)
  • ✕ALT or AST >1000 U/L (>25× ULN)
  • ✕Pregnancy or inadequate contraception in women of childbearing potential or spouses

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00028093
NCT00028093Phase 4Completed
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Combination of Pegylated Interferon and Ribavirin as Therapy for Patients With Chronic Hepatitis C With and Without Renal Disease

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Dec 12, 2001·Updated Nov 8, 2013

In Brief

A Phase 4 clinical trial evaluating Peginterferon alfa-2a with Ribavirin and Peginterferon alfa-2a for Chronic Hepatitis C. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This study will examine the effectiveness of pegylated interferon, or peginterferon (a long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1) infection with and without kidney disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2001
Enrollment StartDec 1, 2001
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 24.6 years ago

Interventions

Peginterferon alfa-2a with Ribavirindrug

Eligible patients were given peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients \<75 kg and 1200 mg daily for patients \>=75 kg) for 48 weeks

Peginterferon alfa-2adrug

Eligible patients were given peginterferon-alpha-2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.