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OpenTrials
Completed

NCT Number: NCT01098097

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peginterferon alpha

Biological

Peginterferon alpha given in combination with ribavirin according to local labeling guidelines

Other names: PegIntron, SCH 054031, MK-4031

Ribavirin

Drug

Ribavirin given in combination with peginterferon alpha according to local labeling guidelines

Other names: Rebetol, SCH 018908, MK-8908

Primary outcomes

  1. Incidence of Serious Adverse Events (SAEs) and/or Clinically Significant Adverse Events (AEs)

    Time frame: Up to 12 Weeks

    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.

  2. Incidence of Thrombocytopenia

    Time frame: Up to 12 Weeks

    Thrombocytopenia is a low blood platelet count

  3. Incidence of Treatment Discontinuations Due to Adverse Events

    Time frame: Up to 12 Weeks

    All treatment discontinuations due to an AE were reported. See Outcome Measure 1 for definition of AEs.

  4. Incidence of Particular Adverse Events Resulting in Treatment Discontinuation

    Time frame: Up to 12 Weeks

    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)

  5. Incidence of Dose Modifications Due to Adverse Events

    Time frame: Up to 12 Weeks

    All dose modifications due to an AE were reported. See Outcome Measure 1 for definition of AEs.

Secondary outcomes

  1. Proportion of Participants Who Achieve Undetectable Hepatitis C Virus Ribonucleic Acid (HCV-RNA)

    Time frame: Week 12

    Participant's blood was tested for HCV-RNA by quantitative polymerase chain reaction. The limit of detection for the assay was 50 IU/mL.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Post Marketing Observational/Non-Interventional Study Of Retreatment Of Chronic Hepatitis C With Peginterferon Alpha And Ribavirin

Acronym: POMOSCH

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2010
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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