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

NCT01098097 | Completed Results

• 1 other identifier: P06011
• Study Type: observational
• Target: 963
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (5)

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

  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.

  Up to 12 Weeks

• Incidence of Thrombocytopenia

  Thrombocytopenia is a low blood platelet count

  Up to 12 Weeks

• Incidence of Treatment Discontinuations Due to Adverse Events

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

  Up to 12 Weeks

• Incidence of Particular Adverse Events Resulting in Treatment Discontinuation

  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)

  Up to 12 Weeks

• Incidence of Dose Modifications Due to Adverse Events

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

  Up to 12 Weeks

Secondary Outcomes (1)

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

  Week 12

Study Arms (1)

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; Drug: Ribavirin

Interventions

Peginterferon alpha BIOLOGICAL

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

Also known as: PegIntron, SCH 054031, MK-4031

Peginterferon alpha and ribavirin

Ribavirin DRUG

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

Also known as: Rebetol, SCH 018908, MK-8908

Peginterferon alpha and ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;
• Willingness of the patient to participate and sign the Informed Consent Form.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: June 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 26, 2014
• Results First Posted: November 20, 2012

Record last verified: 2014-11