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

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 963 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study population

Groups and cohorts

• 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

• BiologicalPeginterferon alpha

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

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

• DrugRibavirin

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

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

Primary outcomes

1. 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.

   Time frame: Up to 12 Weeks

2. Incidence of Thrombocytopenia

   Thrombocytopenia is a low blood platelet count

   Time frame: Up to 12 Weeks

3. 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.

   Time frame: Up to 12 Weeks

4. 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)

   Time frame: Up to 12 Weeks

5. 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.

   Time frame: Up to 12 Weeks

Secondary outcomes

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

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

   Time frame: Week 12

Baseline characteristics