CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Peginterferon alfa-2a +2 moredrug
Likely dose
Peginterferon alfa-2a 90 or 180 mcg/week plus ribavirin 800 mg/dayAI-extracted
Key inclusion· 4
  • ✓Age >18 years
  • ✓Anti-HCV positive in serum
  • ✓Detectable HCV RNA in serum
  • ✓HCV genotype 2 or 3 confirmed by Inno LiPa or direct sequencing; no mixed genotypes with other types
Key exclusion· 14
  • ✕Prior treatment with interferon alpha or peginterferon
  • ✕Decompensated liver disease (bilirubin >4 mg/dL, albumin <3.0 g/dL, PT >2 sec prolonged, or history of esophageal varices, ascites, or hepatic encephalopathy)
  • ✕ALT >1000 U/L (>25× ULN)
  • ✕Significant systemic/major illness (CHF, renal failure, organ transplant, uncontrolled psychiatric disease, angina)

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

Search/NCT00056862
NCT00056862Phase 4Completed
CompareCT.gov

Low Dose Peginterferon and Ribavirin Therapy for Patients With Chronic Hepatitis C Infected With Genotype 2 or 3

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Mar 25, 2003·Updated Dec 6, 2013

In Brief

A Phase 4 clinical trial evaluating Peginterferon alfa-2a and Ribavirin for Hepatitis C. Completed, enrolled 58 participants across 1 site.

Detailed Summary

This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2003
Enrollment StartMar 1, 2003
Primary CompletionJan 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 23.3 years ago

Interventions

Peginterferon alfa-2adrug

Peginterferon alfa-2a 90 mcg/week

Peginterferon alfa-2adrug

180 mcg/week

Ribavirindrug

800 mg/day