- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724893
Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
July 20, 2015 updated by: Merck Sharp & Dohme LLC
Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2430
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen.
Dosing per approved labeling
Other Names:
Ribavirin capsules administered orally.
Dosing in accordance with approved labelling.
Other Names:
|
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.
|
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen.
Dosing per approved labeling
Other Names:
Ribavirin capsules administered orally.
Dosing in accordance with approved labelling.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
Time Frame: Up to 72 weeks
|
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".
|
Up to 72 weeks
|
Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)
Time Frame: Up to 62 weeks
|
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".
|
Up to 62 weeks
|
Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)
Time Frame: Up to 72 weeks
|
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".
|
Up to 72 weeks
|
Number of Participants Achieving SVR (Stage 2)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at six months after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
Time Frame: Up to 48 weeks
|
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
|
Up to 48 weeks
|
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
|
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".
|
Up to 72 weeks
|
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
|
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".
|
Up to 62 weeks
|
Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)
Time Frame: Up to 72 weeks
|
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".
|
Up to 72 weeks
|
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
|
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".
|
Up to 62 weeks
|
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
|
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".
|
Up to 72 weeks
|
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)
Time Frame: Up to 62 weeks
|
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.
|
Up to 62 weeks
|
The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)
Time Frame: Up to 62 weeks
|
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).
|
Up to 62 weeks
|
Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)
Time Frame: Up to 72 weeks
|
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).
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)
Time Frame: Up to 72 weeks
|
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.
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Viral Load (Stage 1)
Time Frame: Up to 72 weeks
|
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).
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Weight (Stage 1)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)
Time Frame: Up to 72 weeks
|
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.
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)
Time Frame: Up to 72 weeks
|
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.
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)
Time Frame: Up to 72 weeks
|
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.
|
Up to 72 weeks
|
Number of Participants Achieving EVR (Stage 1)
Time Frame: From Week 10 to Week 14
|
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".
|
From Week 10 to Week 14
|
Number of Participants Achieving SVR by EVR Type (Stage 1)
Time Frame: Up to 72 weeks
|
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".
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Gender (Stage 1)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Race (Stage 1)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at ≥22 weeks after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants With End of Treatment (EOT) Response (Stage 1)
Time Frame: Up to 48 weeks
|
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".
|
Up to 48 weeks
|
Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)
Time Frame: Up to 72 weeks
|
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.
|
Up to 72 weeks
|
Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)
Time Frame: Week 12
|
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.
|
Week 12
|
Relapse Rate by HCV Genotype (Stage 1)
Time Frame: Up to 48 weeks
|
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.
|
Up to 48 weeks
|
Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)
Time Frame: Up to 48 weeks
|
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.
|
Up to 48 weeks
|
Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)
Time Frame: Week 4
|
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".
|
Week 4
|
Number of Participants Achieving EVR (Stage 2)
Time Frame: Week 12
|
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".
|
Week 12
|
Number of Participants Achieving RVR by Race (Stage 2)
Time Frame: Week 4
|
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".
|
Week 4
|
Number of Participants Achieving EVR by Race (Stage 2)
Time Frame: Week 12
|
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".
|
Week 12
|
Number of Participants Achieving SVR by Race (Stage 2)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at six months after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants Achieving RVR Who Achieved SVR (Stage 2)
Time Frame: Week 4
|
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".
|
Week 4
|
Number of Participants Achieving EVR Who Achieved SVR (Stage 2)
Time Frame: Week 12
|
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".
|
Week 12
|
Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)
Time Frame: Week 4
|
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).
|
Week 4
|
Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)
Time Frame: Week 12
|
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).
|
Week 12
|
Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)
Time Frame: Up to 72 weeks
|
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).
|
Up to 72 weeks
|
Number of Participants Achieving RVR by Weight (Stage 2)
Time Frame: Week 4
|
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment.
Participants with no viral response information were considered viral response "no".
|
Week 4
|
Number of Participants Achieving EVR by Weight (Stage 2)
Time Frame: Week 12
|
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".
|
Week 12
|
Number of Participants Achieving SVR by Weight (Stage 2)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at 24 weeks after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)
Time Frame: Week 4
|
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.
|
Week 4
|
Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)
Time Frame: Week 12
|
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.
|
Week 12
|
Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)
Time Frame: Up to 72 weeks
|
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.
|
Up to 72 weeks
|
Number of Participants Achieving RVR by Gender (Stage 2)
Time Frame: Week 4
|
RVR was defined as undetectable HCV-RNA after 4 weeks of treatment.
Participants with no viral response information were considered viral response "no".
|
Week 4
|
Number of Participants Achieving EVR by Gender (Stage 2)
Time Frame: Week 12
|
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".
|
Week 12
|
Number of Participants Achieving SVR by Gender (Stage 2)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at 24 weeks after EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Number of Participants Achieving RVR by HIV Status (Stage 2)
Time Frame: Week 4
|
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".
|
Week 4
|
Number of Participants Achieving EVR by HIV Status (Stage 2)
Time Frame: Week 12
|
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".
|
Week 12
|
Number of Participants Achieving SVR by HIV Status (Stage 2)
Time Frame: Up to 72 weeks
|
SVR was defined as HCV-RNA negative at six months following EOT.
Participants with no viral response information were considered viral response "no".
|
Up to 72 weeks
|
Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)
Time Frame: Up to 72 weeks
|
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".
|
Up to 72 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 25, 2008
First Posted (Estimate)
July 30, 2008
Study Record Updates
Last Update Posted (Estimate)
August 14, 2015
Last Update Submitted That Met QC Criteria
July 20, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- P04423
- MK-4031-267 (Other Identifier: Merck Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C Viral InfectionUnited States
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
Clinical Trials on PegIFN-2b
-
Foundation for Liver ResearchCompletedChronic Hepatitis BNetherlands, China
-
Merck Sharp & Dohme LLCTerminated
-
Merck Sharp & Dohme LLCCompleted
-
Janssen Pharmaceutical K.K.CompletedHepatitis C, ChronicJapan
-
Merck Sharp & Dohme LLCWithdrawn
-
Merck Sharp & Dohme LLCTerminated
-
Amsterdam UMC, location VUmcMerck Sharp & Dohme LLC; Novartis; Uppsala University HospitalTerminatedChronic Myeloid LeukemiaNetherlands, Denmark, Sweden, Finland, Norway
-
Henan Provincial People's HospitalXiamen Amoytop Biotech Co., Ltd.CompletedChronic Hepatitis BChina
-
Suzhou Ribo Life Science Co. Ltd.Recruiting