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Completed

NCT Number: NCT01289496

Ribavirin Dose Optimization for the Treatment of Hepatitis C

Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a category of patients for whom there is currently no worthwhile therapeutic alternative.

Several studies have shown that there is a relation between plasma ribavirin concentrations and treatment response. Adequate ribavirin plasma concentrations, especially during the first 12 weeks of treatment, should be associated with a better chance of response to the treatment.

The strategy for this study will be to use a loading dose of ribavirin before beginning the treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be reached, and possibly improving the effectiveness of the treatment.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X1P1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin (non-response: HCV-RNA decreased less than 2 logs after 3 months of treatment; relapse: HCV-RNA that becomes positive again after treatment is stopped
  • Compensated hepatic disease (Child-Pugh ≤ 6)
  • Provision by patient of his or her written consent

Exclusion criteria

  • Females who are pregnant or lactating will be excluded
  • Renal failure (estimated glomerular filtration rate < 50 ml/min)
  • A contraindication to treatment with peginterferon plus ribavirin (uncontrolled psychiatric illness, pregnancy/nursing/non-use of effective contraceptive method, uncontrolled epilepsy for at least 6 months, heart failure, unstable angina, hemoglobin < 120 g/L, neutrophils < 1,000/mm3, platelets < 50 x 109/L, or any other condition that, in the investigator's opinion, contraindicates use of the treatment)

Treatment and study plan

Peg-interferon alpha-2a, Ribavirin

Drug
  • 4 weeks RBV priming;
  • 24 or 48 weeks of Pegasys+Ribavirin (RBV) Treatment (depending on genotype);
  • 24 weeks Follow-Up

Patients will receive PEGASYS® 180 µg in 0.5 mL (prefilled syringes) administered sc once weekly. Specific guidelines for adjusting the dose of PEGASYS® are provided in the product monograph.All PEGASYS® administrations will be via the sc route using sterile technique.

Ribavirin 200 mg tablets

Other names: Peg-interféron alpha-2a (PEGASYS), Ribavirin (COPEGUS)

Primary outcomes

  1. Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay

    Time frame: up to 24 weeks post treatment

    Qualitative

Secondary outcomes

  1. Viral Kinetics

    Time frame: up to 24 weeks post treatment

    Plasma Ribavirin (RBV) Assays; Immune Response

  2. Neutrophils

    Time frame: up to 24-48 weeks of treatment

    If neutrophils are < 500/mm, neupogen may be added

  3. Hemoglobin

    Time frame: up to 24-48 weeks of treatment

    If hemoglobin is < 100g/L, erythropoietin and/or transfusions may be prescribed

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  • Hoffmann-La Roche

Registry information

Official study title

Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2011
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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