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

NCT00728494 | Completed Results

• 1 other identifier: P04671
• Study Type: observational
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis C, Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (3)

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

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

  At the end of the 48-week treatment period

• The Number of Participants With a Sustained Virologic Response 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

  Measured at 6 months post-treatment

• The Number of Participants Who Relapsed at 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

  Measured at end of treatment and 6 months post-treatment

Secondary Outcomes (3)

• Average Length of Treatment

  Maximum 48-week treatment duration

• Average Dosage of PegIntron

  Up to 48-week treatment duration

• Average Dosage of Rebetol

  Up to 48-week treatment duration

Study Arms (2)

Treatment and Patient Assistance Program

Patient assistance program was provided to the participants treated with PegIntron/Rebetol. The support program consisted of training by physicians or specialized nurses on the significance of treatment compliance, methods for managing adverse events, and correct drug administration, as well as informational materials and assistance in the management of adverse events.

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908); Behavioral: Patient Assistance Program

Treatment Alone

PegIntron/Rebetol treatment only.

Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908)

Interventions

PegIntron (peginterferon alfa-2b; SCH 54031) BIOLOGICAL

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

Also known as: PegIntron

Treatment Alone; Treatment and Patient Assistance Program

Rebetol (ribavirin; SCH 18908) DRUG

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

Also known as: Rebetol

Treatment Alone; Treatment and Patient Assistance Program

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.

Also known as: Support program

Treatment and Patient Assistance Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic HCV.

You may qualify if:

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

You may not qualify if:

• According to PegIntron/Rebetol label.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin; Allied Health Personnel

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 28, 2015
• Results First Posted: August 19, 2009

Record last verified: 2015-07