Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)

Hepatitis C, Chronic Clinical Trial

— ADEQUATION  

Official title:

Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705666
• Other study ID #: P04437
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: October 1, 2015
• Start date: February 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Not Applicable
• Study type: Observational

Clinical Trial Summary

In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.

Description:

To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C.

Exclusion Criteria:

• Concomitant participation in a clinical trial for the treatment of hepatitis C.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepacivirus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Drug:
• Ribavirin (SCH 18908)
Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting).		Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks.	No