Ribavirin Dose Optimization for the Treatment of Hepatitis C

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01289496
First received: January 25, 2011
Last updated: February 24, 2014
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Peg-interferon alpha-2a, Ribavirin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay [ Time Frame: up to 24 weeks post treatment ] [ Designated as safety issue: No ]
    Qualitative


Secondary Outcome Measures:
  • Viral Kinetics [ Time Frame: up to 24 weeks post treatment ] [ Designated as safety issue: No ]
    Plasma Ribavirin (RBV) Assays; Immune Response

  • Neutrophils [ Time Frame: up to 24-48 weeks of treatment ] [ Designated as safety issue: Yes ]
    If neutrophils are < 500/mm, neupogen may be added

  • Hemoglobin [ Time Frame: up to 24-48 weeks of treatment ] [ Designated as safety issue: Yes ]
    If hemoglobin is < 100g/L, erythropoietin and/or transfusions may be prescribed


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peg-interferon alpha-2a, Ribavirin

Adult patients with chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin(non-response or relapse).

This is a pilot study with no control group.

Drug: Peg-interferon alpha-2a, Ribavirin
  • 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)

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289496

Locations
Canada, Quebec
Centre hospitalier de l'Université de Montréal
Montréal, Quebec, Canada, H2X1P1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Hoffmann-La Roche
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Jean-Pierre Villeneuve, M.D., Ph.D. Centre Hospitalier de l'Université de Montréal
  More Information

Publications:

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01289496     History of Changes
Other Study ID Numbers: ML25553, Control Number: 143155
Study First Received: January 25, 2011
Last Updated: February 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Ribavirin
Pegasys
Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on July 23, 2014