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
  Purpose

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.


Condition Intervention
Hepatitis C
Drug: Standard of Care PegIntron
Drug: Standard of Care Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   None Retained

Blood sample for polymerase chain reaction (PCR) Assay


Enrollment: 2
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01054742     History of Changes
Other Study ID Numbers: P04793 Part 2
Study First Received: January 21, 2010
Results First Received: May 15, 2012
Last Updated: July 18, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014