Status:
TERMINATED
High-dose Ribavirin in Treatment of Chronic Hepatitis C Genotype 1 or 4
Lead Sponsor:
Foundation for Liver Research
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Optimal ribavirin dosages are essential in achieving SVR (sustained virological response). Several studies have shown higher SVR rates in patients receiving higher doses of ribavirin. Therefore we pro...
Detailed Description
Optimal ribavirin dosages are essential in achieving SVR. The initial evidence supporting higher doses of ribavirin for peginterferon alfa-2b comes from a secondary analysis of the pivotal multicenter...
Eligibility Criteria
Inclusion
- hepatitis C genotype 1 or 4
- high viral load (\>400000 IU/ml)
- indication for antiviral treatment or patient's desire for antiviral treatment
- hepatitis C treatment naive
- liver biopsy within 3 years of screening visit or when biopsy is contraindicated e.g in patients with clotting diseases or when a patient refuses to undergo a new biopsy in case the liver biopsy is older than 3 years, substitution by fibroscan is allowed.
- age 18-70 years
Exclusion
- serum bilirubin \>35 μmol/l
- albumin \<36 g/l
- prothrombin time \>4 sec prolonged
- platelets \<90x109/l
- decompensated cirrhosis (Child-Pugh Grade B or C)
- hepatic imaging (ultrasound, CT or MRI) with the evidence of hepatocellular carcinoma (hepatic imaging should be performed within 3 months prior to screening for cirrhotic patients and within 6 months prior to screening for non-cirrhotic patients)
- alcoholic liver disease (indicator: MCV\>100)
- obesity induced liver disease (indicators: steatosis proven by biopsy or ultrasound in association with a body mass index \>30)
- drug related liver disease (indicator: positive history of hepatic toxic drug intake with a causal relation)
- auto-immune hepatitis (indicators: IgG \>30g/l, anti smooth-muscle or antinuclear antibodies titer ³1:40)
- hemochromatosis (indicator: ferritin \>1000 μg/l)
- Wilson's disease (indicator: ceruloplasmin (\<0.2 g/l)
- alpha-1 antitrypsin deficiency (indicator alpha-1 antitrypsin \<0.8 g/L)
- co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- any cardiovascular dysfunction (e.g. cardiac decompensation, myocardial infarction, present or history of arrythmia)
- other medical illness that might interfere with this study: significant pulmonary or renal dysfunction, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g.: steroid therapy, organ transplants other than cornea and hair transplant)
- contra-indications for peginterferon and/or ribavirin:
- severe psychiatric disorder, such as major psychoses, suicidal ideation, suicidal attempt and/or manifest depression. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the subject is clinically stable and that there is ongoing evaluation of the patient's mental status during the study
- visual symptoms related to retinal abnormalities
- pregnancy, breast-feeding or inadequate contraception
- thalassemia, spherocytosis
- females who are pregnant or intending to become pregnant or male partners of females who are pregnant or intending to become pregnant
- absolute neutrophil count (ANC) \<1.40x109/l
- hemoglobin (Hb) \<7.5 mmol/l (female) or \<8.1 mmol/l (male)
- serum creatinine concentration \>1.5 times the upper limit of normal at screening
- substance abuse, such as I.V. drugs or alcohol (indicator: \>28 drinks/week). If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 1 year
- any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00662220
Start Date
April 1 2008
End Date
November 1 2013
Last Update
July 14 2014
Active Locations (27)
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1
Rijnstate
Arnhem, Gelderland, Netherlands, 6815AD
2
St. Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
3
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands, 6532 SZ
4
Atrium Medisch Centrum
Heerlen, Limburg, Netherlands, 6401CX