Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
20. července 2015 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Aktuální)
2430
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Ukázka pravděpodobnosti
Studijní populace
Treatment-naïve patients with chronic hepatitis C undergoing treatment with Pegetron Redipen at approximately 100 centers in Canada.
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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
Ostatní jména:
Ribavirin capsules administered orally.
Dosing in accordance with approved labelling.
Ostatní jména:
|
|
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
Ostatní jména:
Ribavirin capsules administered orally.
Dosing in accordance with approved labelling.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2005
Primární dokončení (Aktuální)
1. srpna 2012
Dokončení studie (Aktuální)
1. srpna 2012
Termíny zápisu do studia
První předloženo
25. července 2008
První předloženo, které splnilo kritéria kontroly kvality
25. července 2008
První zveřejněno (Odhad)
30. července 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
14. srpna 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. července 2015
Naposledy ověřeno
1. července 2015
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce přenášené krví
- Přenosné nemoci
- Onemocnění jater
- Infekce Flaviviridae
- Hepatitida, virová, lidská
- Enterovirové infekce
- Infekce Picornaviridae
- Hepatitida, chronická
- Hepatitida
- Žloutenka typu A
- Hepatitida C
- Hepatitida C, chronická
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antiinfekční látky
- Antivirová činidla
- Antimetabolity
- Antineoplastická činidla
- Imunologické faktory
- Interferony
- Interferon-alfa
- Ribavirin
- Interferon alfa-2
- Peginterferon alfa-2b
Další identifikační čísla studie
- P04423
- MK-4031-267 (Jiný identifikátor: Merck Study Number)
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