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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705666
First received: June 23, 2008
Last updated: November 5, 2014
Last verified: November 2014

June 23, 2008
November 5, 2014
February 2006
July 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
The proportion of patients 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 patients treated for 48 weeks. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00705666 on ClinicalTrials.gov Archive Site
Not Provided
  • To evaluate the proportion of naïve patients, non responders and relapsers at initiation of treatment and the proportion of patients with ALT within the normal range. [ 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 patients treated for 48 weeks. ] [ Designated as safety issue: No ]
  • Dose of PegIntron/Rebetol prescribed; treatment management regarding stopping rule recommendations; maintenance therapy regarding patient profile, dose, duration; deviations from Conference Consensus recommendations; impact of reimbursement of the drug. [ 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 patients treated for 48 weeks. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)
Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin at academic centers, clinics, and private practices in France.

  • Hepatitis C, Chronic
  • Hepacivirus
  • Biological: Peginterferon alfa-2b (SCH 54031)
    Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
    Other Name: PegIntron
  • Drug: Ribavirin (SCH 18908)
    Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.
    Other Name: Rebetol
PegIntron as monotherapy or in combination with Ribavirin.
Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin.
Interventions:
  • Biological: Peginterferon alfa-2b (SCH 54031)
  • Drug: Ribavirin (SCH 18908)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
789
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00705666
P04437
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP