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Adherence in Patients Receiving PegIntron/Rebetol for Hepatitis C in Conjunction With a Psychotherapy Support Program (Study P04252)

NCT00723892 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 614

Last updated 2015-10-30

Study results available
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Summary

Several psychiatric adverse events (eg, depression, fatigue, psychoses, behavior troubles, anxiety, irritability, deteriorated concentration, and insomnia) that are likely to occur during the treatment course with PegIntron plus Rebetol may prompt patients to discontinue their treatment early. The goal of this study is to assess whether a psychotherapy support program may contribute to a better adherence rate.

Conditions

  • Hepatitis C, Chronic
  • Hepacivirus

Interventions

BIOLOGICAL

Peginterferon alfa-2b (PegIntron)

Peginterferon alfa-2b (PegIntron) was administered based on the prescribed dose. The average dose for PegIntron was a weekly injection of 1.5 ± 0.3 μg\^kg\^week

DRUG

Rebetol (Ribavirin)

Rebetol was administered orally based on the prescribed dose. The average dose for Rebetol was 950 ± 167.2 mg\^day

BEHAVIORAL

Psychotherapy support program

Each site has implemented a psychotherapy support program.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-05-31
Completion
2009-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723892 on ClinicalTrials.gov