Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
20 luglio 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
2430
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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
Altri nomi:
Ribavirin capsules administered orally.
Dosing in accordance with approved labelling.
Altri nomi:
|
|
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
Altri nomi:
Ribavirin capsules administered orally.
Dosing in accordance with approved labelling.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2005
Completamento primario (Effettivo)
1 agosto 2012
Completamento dello studio (Effettivo)
1 agosto 2012
Date di iscrizione allo studio
Primo inviato
25 luglio 2008
Primo inviato che soddisfa i criteri di controllo qualità
25 luglio 2008
Primo Inserito (Stima)
30 luglio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
14 agosto 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2015
Ultimo verificato
1 luglio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Infezioni da enterovirus
- Infezioni da Picornaviridae
- Epatite cronica
- Epatite
- Epatite A
- Epatite C
- Epatite C, cronica
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Antimetaboliti
- Agenti antineoplastici
- Fattori immunologici
- Interferoni
- Interferone-alfa
- Ribavirina
- Interferone alfa-2
- Peginterferone alfa-2b
Altri numeri di identificazione dello studio
- P04423
- MK-4031-267 (Altro identificatore: Merck Study Number)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su PegIFN-2b
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Huashan HospitalNon ancora reclutamento
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Foundation for Liver ResearchCompletato
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Merck Sharp & Dohme LLCTerminato
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Merck Sharp & Dohme LLCCompletato
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Merck Sharp & Dohme LLCTerminato
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Janssen Pharmaceutical K.K.CompletatoEpatite C, cronicaGiappone
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Amsterdam UMC, location VUmcMerck Sharp & Dohme LLC; Novartis; Uppsala University HospitalTerminatoLeucemia mieloide cronicaOlanda, Danimarca, Svezia, Finlandia, Norvegia
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Merck Sharp & Dohme LLCCompletatoInfezioni da HIV | Epatite C | Infezione da HCV