Status:
COMPLETED
High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3
Lead Sponsor:
Dr. Conrado Fernandez
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The rate of sustained virological response (SVR) in patients with chronic hepatitis C, genotype 3, high viral load and without rapid virological response (RNA-HCV negative at week 4) is low. Standard ...
Detailed Description
Aims: 1. Efficacy 1.1) Rate of RNA-HCV negative at week 4 and 24 in each arm. 1.2) Rate of SVR in each arm. 2. Safety 2.1) Rate of adverse effects in each arm. Design: Randomized controlled trial. ...
Eligibility Criteria
Inclusion
- HCV Genotype 3
- RNA-HCV \> \> 600.000 IU/ml.
- Compromise to use contraceptive measures on treatment until 6 months after the end of treatment.
Exclusion
- Pregnant or breastfeeding females.
- Concurrent treatment with antineoplastic or immunomodulatory agents, including corticosteroids or radiation therapy over the last 6 months before starting the trial
- Treatment with investigational drugs \< 6 weeks before starting the trial
- Chronic liver disease other than hepatitis C.
- Evidence of hepatocellular carcinoma.
- Evidence of carcinoma hepatocellular
- Decompensated liver disease
- Baseline Neutrophil count \< 1500/cc; or Platelet count \< 90,000/cc
- Baseline Hemoglobin \<12 g/dL in females o \<13 g/dL in males.
- Increased risk of anemia(Eg, thalassemia, spherocytosis..).
- Ischemic heart disease or cerebrovascular disease.
- Serum creatinine \>1.5 times upper limit of normality.
- History of severe psychiatric conditions (Major antidepressives or neuroleptic drugs required for major depression or psychosis), suicide attempts or psychiatric disability .
- History of convulsive disorders.
- Immunological conditions.
- Chronic Obstructive Lung Disease with limited functionality
- Severe heart disease or congestive cardiac insufficiency cardiopathy grave.
- Advanced atherosclerosis
- Solid organ or bone marrow transplant.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00830609
Start Date
November 1 2008
End Date
December 1 2011
Last Update
March 13 2012
Active Locations (28)
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1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
3
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, Spain, 08036
4
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907