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Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM1) - NCT01023035-27710(Clinical Trial 560514)



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City:  Durham
State:  
NC
Zip Code: 27710
Conditions: Hepatitis C, Chronic
Purpose: This study involves treatment with boceprevir in combination with PegIntron (PEG2b) + ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 1. All subjects will begin treatment in the Pending Randomization Arm and will be treated with 4 weeks of PEG2b/RBV followed by 44 weeks of boceprevir plus PEG2b/RBV. Subjects will continue in the Pending Randomization Arm if their serum hemoglobin remains >10 g/dL throughout the 48 week treatment period. Subjects who become anemic (serum hemoglobin of approximately <=10 g/dL) within the 48-week treatment period will be randomized to Arm 1 (RBV dose reduction) or Arm 2 (erythropoietin use) for management of the anemia. The total duration of therapy for all subjects will be 48 weeks. The primary objective of this trial is to compare the effect on efficacy of erythropoietin use versus RBV dose reduction for the management of anemia in subjects who become anemic during the treatment of CHC genotype 1 infection with boceprevir plus PEG2b/RBV therapy. It is suggested that an appropriate anemia management strategy may allow subjects to remain on optimal therapy and increase their ability to achieve SVR
Study summary:
Criteria: Inclusion Criteria: - Subject must have previously documented CHC genotype 1 infection. - Hemoglobin concentration at Screening must be <=15 g/dL for both females and males. - Subject must have a liver biopsy with histology consistent with CHC and no other etiology. - Subjects with bridging fibrosis (F3) or cirrhosis (F4) must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma. - Subject must be >=18 years of age. - Subject's weight must be >=40 kg and <=125 kg. - Subject and subject's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. - Subjects must be willing to give written informed consent. - Subjects must be willing to attend frequent site visits for the duration of the trial. - Subjects must not have any contraindications for the use of erythropoietin. Exclusion Criteria: - Subjects known to be coinfected with the human immunodeficiency virus (HIV) or hepatitis B virus. - Subjects who received prior treatment for hepatitis C. - Treatment with any investigational drug within 30 days of the screening visit in this trial. - Subjects receiving any of the following medication(s) within 2 weeks prior to the Day 1 visit: alfuzosin, antiarrhythmics (amiodarone, bepridil, flecainide, propafenone, and quinidine), ergot derivatives, cisapride, lovastatin, simvastatin, pimozide, triazolam, and orally administered midazolam. - Participation in any other clinical trial within 30 days of the screening visit in this trial or intention to participate in another clinical trial during participation in this trial. - Evidence of decompensated liver disease. - Diabetic and/or hypertensive subjects with clinically significant ocular examination findings. - Pre-existing psychiatric condition(s). - Clinical diagnosis of substance abuse of specified drugs within specified timeframes. - Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the trial. - Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). - Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the trial period. Male subjects with partners who are, or intend to become, pregnant during the trial period. - Any other condition which, in the opinion of a physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the trial. - Subjects who had a life-threatening serious adverse event during the screening period. - A subject must not be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial. - Protocol-specified hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve trial entry requirements). - Serum albumin below the lower limit of normal (LLN) of laboratory reference range. - Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference. - Serum creatinine >ULN of the laboratory reference. - Protocol-specified serum glucose concentrations. - Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory reference range. - Protocol-specified alpha fetoprotein concentrations
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Data Source: ClinicalTrials.gov
Date Processed: July 12, 2010
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