Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01054742
First received: January 21, 2010
Last updated: July 18, 2012
Last verified: July 2012

January 21, 2010
July 18, 2012
December 2009
June 2011   (final data collection date for primary outcome measure)
Number of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Levels During Part 2 of the Study [ Time Frame: From Day 1, Week 1 [Part 2 ] through Follow-up Week 24 [ Part 2] ] [ Designated as safety issue: No ]
A quantitative polymerase chain reaction (PCR) assay was used to measure HCV-RNA.
Relapse rate in HCV LVL G1 patients [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01054742 on ClinicalTrials.gov Archive Site
Not Provided
Proportion of patients (%) with sustained virological response [ Time Frame: 24 weeks post treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)
PREDICT (Part 2)- Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With HCV Genotype 1 Low Viral Load (HCV LVL 1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

All study activities were consistent with the EU Directive 2001/20/EC section for non-interventional studies (i.e. observational studies). Medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the participant to a particular therapeutic strategy is not decided in advance by the trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

Blood sample for polymerase chain reaction (PCR) Assay

Non-Probability Sample

Only participants who were originally treated in study P04793 and relapsed during the 24 week follow up phase were offered the chance to receive retreatment with PegIntron and ribavirin for up to an additional 48 weeks.

Hepatitis C
  • Drug: Standard of Care PegIntron
    Commercially available PegIntron administered subcutaneously (SC) at 1.5 μg/kg weekly in accordance with the PegIntron Summary of Product Characteristics (SmPC).
    Other Names:
    • peginterferon alfa-2b
    • PEG2b
    • SCH 054031
  • Drug: Standard of Care Ribavirin
    Commercially available ribavirin administered orally at 800-1200 mg/day based on body weight in accordance with the ribavirin SmPC.
    Other Names:
    • REBETOL;
    • SCH 018908
Standard of Care PegIntron Plus Ribavirin [Part 2]
Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribavirin for 48 weeks.
Interventions:
  • Drug: Standard of Care PegIntron
  • Drug: Standard of Care Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willingness to participate
  • 18 years or older, either gender, any race
  • Participant has relapsed at the end of the Part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the Week 24 end-of-treatment time point)
  • Participant considered suitable for treatment per local label
  • Investigator considers suitable and participant consents to be treated

Exclusion Criteria:

  • Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
  • Participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the SmPC
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01054742
P04793 Part 2
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2012

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