Post Marketing Observational Study of Retreatment of Chronic Hepatitis C With Peginterferon Alpha and Ribavirin (Study P06011) (POMOSCH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01098097
First received: April 1, 2010
Last updated: October 17, 2012
Last verified: October 2012
  Purpose

To study retreatment in patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin in a real-life setting in an observational/noninterventional study.


Condition Intervention
Hepatitis C, Chronic
Biological: Peginterferon alpha
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs) [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant administered a medicinal product which did not necessarily have a causal relationship to the treatment. All AEs reported in the study were judged by the investigator to be clinically significant. An SAE was any adverse drug experience that resulted in death, was life-threatening, caused or prolonged hospitalization, caused persistent or significant disability or incapacity, caused a congenital anomaly or birth defect, or may have required medical or surgical intervention to prevent one of these outcomes.

  • Incidence of Thrombocytopenia [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
    Thrombocytopenia is a low blood platelet count

  • Incidence of Treatment Discontinuations Due to Adverse Events [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
    All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.

  • Incidence of Particular Adverse Events Resulting in Treatment Discontinuation [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]

    All treatment discontinuations due to particular AEs were reported. These discontinuations included treatment stopped (TS) and dose reduced followed by treatment stopped (DR/TS).

    The particular AE evaluated were anemia (low red blood cells), leucopenia (low white blood cells), neutropenia (low blood neutrophils), thrombocytopenia (low blood platelets), esophageal varices (dilated veins in lower esophagus), splenomegaly (enlarged spleen), portal hypertensive gastropathy (changes in stomach mucosa), and hepatomegaly (enlarged liver)


  • Incidence of Dose Modifications Due to Adverse Events [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: Yes ]
    All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.


Secondary Outcome Measures:
  • Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.


Enrollment: 963
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Peginterferon alpha and ribavirin
Peginterferon alpha and ribavirin will be administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
Biological: Peginterferon alpha
Peginterferon alpha given in combination with ribavirin according to local labeling guidelines
Other Names:
  • PegIntron
  • SCH 054031
  • MK-4031
Drug: Ribavirin
Ribavirin given in combination with peginterferon alpha according to local labeling guidelines
Other Names:
  • Rebetol
  • SCH 018908
  • MK-8908

Detailed Description:

This is an observational/non interventional study to collect data on the patient characteristics of those seeking retreatment as well as safety and efficacy information during the first 12 weeks of retreatment.

  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

Patients who failed prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin

Criteria

Inclusion Criteria:

  • Chronic hepatitis C of any genotype;
  • Prior treatment with interferon alpha (pegylated or non-pegylated) with or without ribavirin did not result in a sustained virological response;
  • Inclusion criteria listed on the approved label in each country;
  • Willingness of the patient to participate and sign the Informed Consent Form.

Exclusion Criteria:

  • Patient exclusion from this observational/non-interventional study will be determined by the treating physician and will be based on the local label in each country.
  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: NCT01098097     History of Changes
Other Study ID Numbers: P06011
Study First Received: April 1, 2010
Results First Received: October 17, 2012
Last Updated: October 17, 2012
Health Authority: Russia: Ethics Committee at the Federal Service on Surveillance in Healthcare and Social Development

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014