A Study to Assess Treatment with PEG-Intron® and Rebetol® in Naïve Patients with Genotype 1 Chronic Hepatitis C and Slow Virological Response - Slow responder study
- Conditions
- Chronic Hepatitis C, Genotype 1
- Registration Number
- EUCTR2004-000488-83-ES
- Lead Sponsor
- Intergrated Therapeutics Group, Incorporated-a subsidiary of Schering Plough
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1200
All previously untreated (naïve), genotype-1 chronic hepatitis C patients are eligible for enrollment in this protocol.
1.Adult subjects aged 18 to 70 years, of either sex.
2.Genotype-1 HCV-RNA-positive patients.
3.Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits):
a)Hemoglobin values of >12 gm/dL for females and 13 gm/dL for males.
b)WBC >3,000/mm3
c)Neutrophil count >1,500/mm3
d)Platelet count >80,000/mm3
e)Direct bilirubin WNL
f)Indirect bilirubin WNL (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be <3.0 mg/dL (<51.3 µmol/L)
g)Albumin WNL
h)Serum creatinine WNL
i)ALT level above ULN at screening
4.At the Screen Visit, fasting glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be <140 mg/dL and HbA1C <8.5%. HbA1C must be <8.5% in diabetic subjects (whether on medication or diet controlled). ANA must be ? 1:320
5.Thyroid Stimulating Hormone (TSH) WNL whether in euthyroid subjects or subjects requiring medical treatment. (subjects requiring medication to maintain TSH levels within normal limits are eligible if all other inclusion/exclusion criteria are met)
6.Double-barrier contraception for female subjects until 6 months post-treatment, for male subjects until 7 months post-treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with some interferon or ribavirin product, whether alone or in combination.
2.Subjects weighing over 125 kg.
3.Suspected hypersensitivity to any interferon or ribavirin product.
4.Coinfection with HBV, HIV, or both.
5.HCV genotype 2, 3, 4, or other non-1 genotype
6.Any cause of liver disease other than chronic hepatitis C, including but not limited to:
a)Hemochromatosis
b)Alpha-1 antitrypsin deficiency
c)Wilson's disease
d)Autoimmune hepatitis
e)Alcoholic liver disease
f)Non-alcoholic steatohepatitis (NASH)
g)Drug-related liver disease
7.Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma)
8.Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia)
9.Known G6PD deficiency
10.Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.
11.Subjects with organ transplants, except for corneal or hair transplant.
12.Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:
a)Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:
?hospitalization for depression
?electroconvulsive therapy for depression, or
?depression causing a prolonged absence from work or significantly altering daily functions.
Patients with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the patient; this management plan will become a part of the patient's medical record.
b)Craniocerebral trauma which is not a concussion, or active seizure disorders requiring medication.
c)Clinically significant ECG abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia).
d)Chronic lung disease (e.g., chronic obstructive lung disease)
e)Poorly controlled diabetes mellitus
f)Immune-mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)
g)Clinical gout
13.Subject is or was a substance abuser, such as alcohol (= 80 gm/day), methadone, IV, oral or inhaled drugs. To be considered for inclusion into the protocol, the subject must have abstained and agree to abstain from using any of the above for at least 6 months. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether 72-weeks of treatment with peginteron alpha-2b plus ribavirin is more effective than 48-weeks of treatment in naive, genotype 1 hepatitis C patients with slow response (i.e., patients who are HCV-RNA-positive, with an equal or more than 2 log drop in viral load at week 12 as well as HCV-RNA negative at week 24);Secondary Objective: To evaluate the safety of 72 weeks of treatment with peginterferon alpha 2b plus ribavirin, and to compare it with those patients who receive treatment for 48 weeks;Primary end point(s): Comparison of Sustained Virological Response at week 24 follow-up between slow-responder patients treated for 48 weeks and treated for 72 weeks.
- Secondary Outcome Measures
Name Time Method