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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00705666
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : June 24, 2010
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date June 23, 2008
First Posted Date June 26, 2008
Results First Submitted Date March 30, 2010
Results First Posted Date June 24, 2010
Last Update Posted Date October 2, 2015
Study Start Date February 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2010)
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. ]
Original Primary Outcome Measures
 (submitted: June 25, 2008)
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. ]
Change History Complete list of historical versions of study NCT00705666 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 25, 2008)
  • 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. ]
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)
Official Title Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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.
Condition
  • Hepatitis C, Chronic
  • Hepacivirus
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.
    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
Study Groups/Cohorts 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 25, 2008)
789
Original Actual Enrollment Same as current
Actual Study Completion Date July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00705666
Other Study ID Numbers P04437
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2015