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Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus
This study is ongoing, but not recruiting participants.
Sponsored by: Valeant Pharmaceuticals North America
Information provided by: Valeant Pharmaceuticals North America
ClinicalTrials.gov Identifier: NCT00446134
  Purpose

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

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2b
U.S. FDA Resources
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

Further study details as provided by Valeant Pharmaceuticals North America:

Primary Outcome Measures:
  • Proportion of patients with either undetectable serum HCV RNA or at least a 2-log decrease from baseline in serum HCV RNA at treatment week 12. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety measures include hemoglobin <10 g/dL. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]
  • Efficacy measures include HCV RNA < 100 copies/mL and/or at least a 2-log decrease from baseline, HCV RNA <2 copies/mL; normalization of ALT. [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

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
Drug: Taribavirin
oral tablet
Drug: taribavirin
Tablet
Group 2: Drug: Experimental
Oral taribavirin tablet 25 mg/kg/day
Drug: taribavirin
Oral Tablet
Group 3: Drug: Experimental
Oral taribavirin 30 mg/kg/day
Drug: taribavirin
Oral Tablet
Group 4: Drug: Active Comparator
Oral ribavirin 800 - 1400 mg/kg/day
Drug: ribavirin
Oral Tablets

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subject Inclusion Criteria

To be eligible for enrollment, patients must meet all of the following criteria:

  1. At least 18 years of age
  2. Diagnosed with compensated chronic HCV genotype 1 infection that has not been treated with interferon, peginterferon, ribavirin or any experimental therapy for >28 days

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:

  1. Positive HIV or HbsAg serology
  2. Severe psychiatric or neuropsychiatric disorders including severe depression, history of suicidal ideations or suicide attempt(s). (This would include patients with a history of suicidal ideations or suicide attempt(s) that occurred when the patient was a minor or many years ago; if the event occurred while under the influence of alcohol or drugs; if the suicidal ideations or suicide attempt(s) were connected to a traumatic event; if the patient was not hospitalized or treated; if the patient has obtained psychiatric clearance for treatment)
  3. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease
  4. History of thalassemia or other hemoglobinopathies (even if the hemoglobin is normal)
  5. Chronic hepatic disease other than hepatitis C
  6. Organ or bone marrow transplant
  7. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study
  8. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study
  9. Males whose female partners are pregnant
  10. Patients who have had a malignancy diagnosed and/or treated within the past 5 years, except for localized squamous or basal cell cancers treated by local excision
  11. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening
  12. History of alcoholism or drug addiction 1 year prior to screening
  13. The use of methadone, buprenorphine or any similar drug, regardless of the prescribed indication or the length of time the patient has been on the drug
  14. Chronic (>4 weeks duration) diarrhea, including irritable bowel disease
  15. Fibrosis score F4 (cirrhosis) based on Metavir or equivalent index
  16. Weight >128 kg or <40 kg
  17. Patients infected with mixed HCV genotypes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446134

Locations
United States, California
Cedars-Sinai Medical Center, 8635 W. 3rd Street, Suite 590W
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Valeant Pharmaceuticals North America
Investigators
Principal Investigator: Fred Poordad, MD Cedars-Sinai Medical Center
  More Information

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

Keywords provided by Valeant Pharmaceuticals North America:
Phase 2b Dose-Ranging Study

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009