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Ribavirin Dose Optimization for the Treatment of Hepatitis C

C

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase

Completed
Phase 2

Conditions

Chronic Hepatitis C

Treatments

Drug: Peg-interferon alpha-2a, Ribavirin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01289496
Control Number: 143155 (Other Identifier)
ML25553

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Peg-interferon alpha-2a, Ribavirin
Experimental group
Description:
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.
Treatment:
Drug: Peg-interferon alpha-2a, Ribavirin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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