Clinical trial NCT01289496: Ribavirin Dose Optimization for the Treatment of Hepatitis C
Official title: Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Ribavirin
Pegasys
Hepatitis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2011-02-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay
timeFrame: up to 24 weeks post treatment
Secondary outcomes:
measure: Viral Kinetics
timeFrame: up to 24 weeks post treatment
measure: Neutrophils
timeFrame: up to 24-48 weeks of treatment
measure: Hemoglobin
timeFrame: up to 24-48 weeks of treatment
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jean-Pierre Villeneuve, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsubota A, Hirose Y, Izumi N, Kumada H. Pharmacokinetics of ribavirin in combined interferon-alpha 2b and ribavirin therapy for chronic hepatitis C virus infection. Br J Clin Pharmacol. 2003 Apr;55(4):360-7. doi: 10.1046/j.1365-2125.2003.01780.x.
citation: Wade JR, Snoeck E, Duff F, Lamb M, Jorga K. Pharmacokinetics of ribavirin in patients with hepatitis C virus. Br J Clin Pharmacol. 2006 Dec;62(6):710-4. doi: 10.1111/j.1365-2125.2006.02704.x.
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