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Completed

NCT Number: NCT00728494

Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)

Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C 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

Observational

About this study

Non-Probability Sample, Commercial product used according to EU label.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • According to PegIntron/Rebetol label.
  • Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion criteria

  • According to PegIntron/Rebetol label.

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031)

Biological

Peginterferon alfa-2b will be administered according to the product's labeling.

Other names: PegIntron

REBETOL (ribavirin; SCH 18908)

Drug

Ribavirin will be administered according to the product's labeling.

Other names: Rebetol

Patient assistance program

Behavioral

The patient assistance program includes the following:

  • Training by physicians or specialized nurses.
  • Informational materials based on the "To beat HCV" program.
  • Management of specific side effects.

Other names: Support program

Primary outcomes

  1. The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C

    Time frame: At the end of the 48-week treatment period

    Participant adherence to therapy was compared between participants treated with PegIntron/Rebetol either with or without a patient assistance program

  2. The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment

    Time frame: Measured at 6 months post-treatment

    Sustained virologic response is defined as having an undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of treatment and 6 months post-treatment

  3. The Number of Participants Who Relapsed at 6 Months Post-treatment

    Time frame: Measured at end of treatment and 6 months post-treatment

    Participants who relapse are defined as having an undetectable HCV-RNA at the end of treatment but detectable HCV-RNA at 6 months post-treatment

Secondary outcomes

  1. Average Length of Treatment

    Time frame: Maximum 48-week treatment duration

    Participant adherence to therapy was compared between participants who received vs not received a patient assistance program in addition to their PegIntron/Rebetol treatment.

  2. Average Dosage of PegIntron

    Time frame: Up to 48-week treatment duration

    Dosage of PegIntron was expressed in terms of micrograms of PegIntron received per kilogram of participant's body weight per week

  3. Average Dosage of Rebetol

    Time frame: Up to 48-week treatment duration

    Rebetol dosage was expressed in milligrams per kilogram of body weight per day.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 5, 2008
Registry last updated
Jul 28, 2015

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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