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

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.

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Key information

Conditions

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

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

peginterferon alfa-2b (SCH 54031)

Biological

Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Other names: PegIntron

Ribavirin (SCH 18908)

Drug

Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.

Other names: Rebetol

Primary outcomes

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).

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: ADEQUATION

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jun 26, 2008
Registry last updated: Oct 2, 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.

Published trials that share one or more normalized conditions with this study.

Completed