High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3
DARGEN-3
Effect of High Dose vs. Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3, High Viral Load Without Rapid Virological Response
1 other identifier
interventional
101
1 country
28
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 of care of these patients include treatment with weekly peginterferon plus 800 mg/day of ribavirin (RBV). Extended treatment to 48 weeks does not provide more clinical benefit than the standard duration. The main hypothesis is that higher dose of ribavirin may be better in terms of SVR than the standard dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2008
Typical duration for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 13, 2012
March 1, 2012
2.8 years
January 27, 2009
March 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment.
1 year
Secondary Outcomes (1)
Rate of patients with undetectable RNA-HCV in each arm at week 4 and 24 of treatment. Rate of adverse effects in each arm.
1 year
Study Arms (3)
A
ACTIVE COMPARATORPatients in this arm will receive standard of care (Peginterferon alfa 2A 180 mcg/weeks SC plus ribavirin 800 mg/day for 24 weeks).
B1
EXPERIMENTALAfter a period of 4 weeks with peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day (Induction phase), these patients will be allocated according to negativity or positivity of RNA-HCV at week 4. If RNA-HCV negative, treatment with peginterferon alfa 2 a 180 mcg/week plus RBV 800 mg/day (SOC) will be continued over 20 additional weeks (Arm B1). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin \> 12g/dL.
B2
EXPERIMENTALIf RNA-HCV at week 4 remains positive after the induction phase, then peginterferon alfa 2 a 180 mcg/week plus RBV 1600 mg/day will be continued for 20 additional weeks (Arm B2). Epo β (450 IU/kg/week) will be administered as required to maintain hemoglobin \> 12g/dL.
Interventions
Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 800 mg/day po (Control Group) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epoetin β (450 IU/kg/week) SC over 4 weeks (Arm B1) Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day po plus Epo beta 450 UI over four weeks (Arm B1) If RNA-HCV positive at week 4, Peginterferon alfa 2 A 180 mcg/week SC plus Ribavirin 1,600 mg/day plus Epo beta 450 UI to keep Hb\>12 g/dL if required over 20 additional weeks (Arm B2)
Ribavirin 1,600 mg/day plus peginterferon alfa 2A 180 mcg/week plus Epo beta 450 IU/Kg/day to maintain Hb\>12g/dl over 4 or 24 weeks
Peginterferon alfa 2 a 180 mcg/week for 4 weeks and then peginterferon alfa 2A for 20 weeks
Eligibility Criteria
You may qualify if:
- HCV Genotype 3
- RNA-HCV \> \> 600.000 IU/ml.
- Compromise to use contraceptive measures on treatment until 6 months after the end of treatment.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18004, Spain
Hospital San Cecilio
Granada, Granada, Spain
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital de León
León, León, 24071, Spain
Hospital Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital de Getafe
Getafe, Madrid, 28901, Spain
Hospital La Princesa
Madrid, Madrid, 28006, Spain
Hospital Gregorio Marañon
Madrid, Madrid, 28007, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28021, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Costa del Sol
Marbella, Málaga, 29603, Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Málaga, 29010, Spain
Hospital Central de Asturias
Oviedo, Oviedo, 33006, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Salamanca, 37007, Spain
Hospital de Valme
Seville, Sevilla, 41014, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47005, Spain
Hospital Santiago Apóstol
Vitoria-Gasteiz, Vitoria, 01004, Spain
Hospital Clínico de Zaragoza
Zaragoza, Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Related Publications (1)
Fernandez-Rodriguez CM, Morillas RM, Masnou H, Navarro JM, Barcena R, Gonzalez JM, Martin-Martin L, Poyato A, Miquel-Planas M, Jorquera F, Casanovas T, Salmeron J, Calleja JL, Sola R, Alonso S, Planas R, Romero-Gomez M. Randomized clinical trial comparing high versus standard dose of ribavirin plus peginterferon alfa-2a in hepatitis C genotype 3 and high viral load. Dargen-3 study. Gastroenterol Hepatol. 2014 Jan;37(1):1-8. doi: 10.1016/j.gastrohep.2013.10.005. Epub 2013 Dec 17.
PMID: 24360571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Conrado M Fernandez-Rodriguez
Hospital Universitario Fundacion Alcorcon; University Rey Juan Carlos.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 28, 2009
Study Start
November 1, 2008
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
March 13, 2012
Record last verified: 2012-03