Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724893
First received: July 25, 2008
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
Biological: PegIFN-2b
Drug: Ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) [ Time Frame: Up to 62 weeks ] [ Designated as safety issue: No ]
    This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".


Secondary Outcome Measures:
  • Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment

  • Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) [ Time Frame: Up to 62 weeks ] [ Designated as safety issue: No ]
    Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  • The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) [ Time Frame: Up to 62 weeks ] [ Designated as safety issue: No ]
    Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  • The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  • The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1) [ Time Frame: Up to 62 weeks ] [ Designated as safety issue: No ]
    Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1) [ Time Frame: Up to 62 weeks ] [ Designated as safety issue: No ]
    Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  • Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  • Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants Achieving SVR by Viral Load (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).

  • Number of Participants Achieving SVR by Weight (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants Achieving EVR (Stage 1) [ Time Frame: From Week 10 to Week 14 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by EVR Type (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Gender (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Race (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants With End of Treatment (EOT) Response (Stage 1) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no".

  • Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Relapse Rate by HCV Genotype (Stage 1) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
    The relapse rate was calculated with these parameters: EOT "yes", EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1) [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  • Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving EVR (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving RVR by Race (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving EVR by Race (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Race (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving RVR Who Achieved SVR (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving EVR Who Achieved SVR (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  • Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  • Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  • Number of Participants Achieving RVR by Weight (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving EVR by Weight (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Weight (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

  • Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

  • Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

  • Number of Participants Achieving RVR by Gender (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving EVR by Gender (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by Gender (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving RVR by HIV Status (Stage 2) [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving EVR by HIV Status (Stage 2) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  • Number of Participants Achieving SVR by HIV Status (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response "no".

  • Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2) [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
    Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered "always" or "most of the time" to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".


Enrollment: 2430
Study Start Date: August 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Stage 1 Participants
Participants with CHC receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
Biological: PegIFN-2b
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
Other Names:
  • Pegetron®
  • Pegylated interferon alfa-2b
  • PegIntron
  • SCH 054031
Drug: Ribavirin
Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
Other Name: SCH 018908
Stage 2 Participants
Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
Biological: PegIFN-2b
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
Other Names:
  • Pegetron®
  • Pegylated interferon alfa-2b
  • PegIntron
  • SCH 054031
Drug: Ribavirin
Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
Other Name: SCH 018908

  Eligibility

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

Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.

Criteria

Inclusion Criteria:

  • Treatment-naïve patients with chronic hepatitis C
  • Adults (>18 years of age)
  • Prescribed Pegetron Redipen
  • Must meet all requirements for treatment with Pegetron Redipen
  • Must be able to obtain reimbursement of medication through private or provincial coverage

Exclusion Criteria:

  • Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
  • HIV antibody positive
  • Post liver transplant patients
  • Any other exclusion criteria as per the product Monograph
  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: NCT00724893     History of Changes
Other Study ID Numbers: P04423, MK-4031-267
Study First Received: July 25, 2008
Results First Received: July 29, 2013
Last Updated: August 15, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 20, 2014