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Sponsored by: |
Valeant Pharmaceuticals North America |
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Information provided by: | Valeant Pharmaceuticals North America |
ClinicalTrials.gov Identifier: | NCT00446134 |
The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic HCV genotype 1 infection.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: Taribavirin Drug: taribavirin Drug: ribavirin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Comparison of Weight-Based Doses of Taribavirin Combined With Peginterferon Alfa 2b Versus Ribavirin Combined With Peginterferon Alfa 2b in Therapy-naïve Patients With Chronic Hepatitis C Virus Genotype 1 Infection |
Estimated Enrollment: | 260 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group 1: Drug: Experimental
Oral Taribavirin 20 mg/kg/day
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Drug: Taribavirin
oral tablet
Drug: taribavirin
Tablet
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Group 2: Drug: Experimental
Oral taribavirin tablet 25 mg/kg/day
|
Drug: taribavirin
Oral Tablet
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Group 3: Drug: Experimental
Oral taribavirin 30 mg/kg/day
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Drug: taribavirin
Oral Tablet
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Group 4: Drug: Active Comparator
Oral ribavirin 800 - 1400 mg/kg/day
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Drug: ribavirin
Oral Tablets
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The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 mg/day to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic HCV genotype 1 infection.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subject Inclusion Criteria
To be eligible for enrollment, patients must meet all of the following criteria:
2a Serum HCV RNA >2000 copies/mL (780 IU/mL) 2b Liver biopsy performed within 3 years prior to screening consistent with chronic HCV infection 2c Criteria for compensated HCV infection, including normal prothrombin time, serum albumin and bilirubin levels (unless due to non-hepatitis factors) and no history or evidence of bleeding esophageal varices, ascites, or hepatic encephalopathy
3 History of alanine aminotransferase (ALT) elevation either within 6 months prior to screening, at screening, or on retest 2 weeks after a negative screening test, or histologic evidence of HCV infection and a detectable viral load
4 Platelet count ≥90,000/mm3
5 Absolute neutrophil count ≥1200/mm3
6 Hemoglobin ≥12.0 g/dL for females or ≥13.0 g/dL for males
7 Antinuclear antibody (ANA) titer ≤1:320
8 Serum creatinine <1.5 mg/dL
9 HbA1c ≤8.5% for diabetic patients
10 Normal or adequately controlled TSH on prescription medication
11 Alpha fetoprotein (AFP) <20 ng/mL or hepatocellular carcinoma ruled out (ultrasound, CT or MRI scan) within 6 months prior to the study (Patients with an AFP >20 ng/mL must have ongoing hepatocellular carcinoma screening during study as part of the patient's routine medical care)
12 All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator
13 Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose
14 Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent
Subject Exclusion Criteria
Patients who have any of the following during the screening or Day 1 visit are not eligible for enrollment in this study:
United States, California | |
Cedars-Sinai Medical Center, 8635 W. 3rd Street, Suite 590W | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | Fred Poordad, MD | Cedars-Sinai Medical Center |
Responsible Party: | Valeant Research & Development ( Eric Chun, Director Clinical Operations ) |
Study ID Numbers: | RNA003142-204 |
Study First Received: | March 8, 2007 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00446134 |
Health Authority: | United States: Food and Drug Administration |
Phase 2b Dose-Ranging Study |
Virus Diseases Body Weight Hepatitis Signs and Symptoms Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Ribavirin Peginterferon alfa-2b Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action |
Flaviviridae Infections Therapeutic Uses Antiviral Agents Pharmacologic Actions |