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

20. juli 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2430

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Biologisk: PegIFN-2b
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
Andre navne:
  • SCH 054031
  • PegIntron
  • Pegyleret interferon alfa-2b
  • Pegetron®
Medicin: Ribavirin
Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
Andre navne:
  • SCH 018908
Stage 2 Participants
Participants with CHC Genotype 1 receiving PegIFN-2b using Redipen™ formulation (1.5 mcg/kg) once weekly and ribavirin capsules (800-1400 mg) daily according to routine medical practice at participating study sites.
Biologisk: PegIFN-2b
PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling
Andre navne:
  • SCH 054031
  • PegIntron
  • Pegyleret interferon alfa-2b
  • Pegetron®
Medicin: Ribavirin
Ribavirin capsules administered orally. Dosing in accordance with approved labelling.
Andre navne:
  • SCH 018908

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2005

Primær færdiggørelse (Faktiske)

1. august 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

25. juli 2008

Først indsendt, der opfyldte QC-kriterier

25. juli 2008

Først opslået (Skøn)

30. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P04423
  • MK-4031-267 (Anden identifikator: Merck Study Number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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