- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01241760
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.
Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Adelaide, Australien
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Camperdown, Australien
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Clayton, Australien
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Darlinghurst, Australien
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Fitzroy, Australien
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Greenslopes, Australien
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Melbourne, Australien
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Perth, Australien
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Antwerpen, Belgien
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Brussels, Belgien
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Genk, Belgien
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Gent, Belgien
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Leuven, Belgien
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Liege, Belgien
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Campinas, Brasilien
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Salvador, Brasilien
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Santo Andre, Brasilien
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Sao Paulo, Brasilien
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São Paulo, Brasilien
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Birmingham, Det Forenede Kongerige
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Edinburgh, Det Forenede Kongerige
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Glasgow, Det Forenede Kongerige
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London, Det Forenede Kongerige
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Manchester, Det Forenede Kongerige
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California
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La Jolla, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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San Diego, California, Forenede Stater
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Colorado
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Aurora, Colorado, Forenede Stater
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Connecticut
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New Haven, Connecticut, Forenede Stater
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Florida
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Bradenton, Florida, Forenede Stater
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Jacksonville, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Marietta, Georgia, Forenede Stater
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Illinois
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Chicago, Illinois, Forenede Stater
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Downers Grove, Illinois, Forenede Stater
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Louisiana
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New Orleans, Louisiana, Forenede Stater
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Maryland
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Lutherville, Maryland, Forenede Stater
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Missouri
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Kansas City, Missouri, Forenede Stater
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater
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New Jersey
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Egg Harbor Twp, New Jersey, Forenede Stater
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New Mexico
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Santa Fe, New Mexico, Forenede Stater
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New York
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New York, New York, Forenede Stater
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North Carolina
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Charlotte, North Carolina, Forenede Stater
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Durham, North Carolina, Forenede Stater
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Statesville, North Carolina, Forenede Stater
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Winston Salem, North Carolina, Forenede Stater
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Ohio
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Cincinnati, Ohio, Forenede Stater
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater
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Hershey, Pennsylvania, Forenede Stater
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Philadelphia, Pennsylvania, Forenede Stater
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Pittsburgh, Pennsylvania, Forenede Stater
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Rhode Island
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Providence, Rhode Island, Forenede Stater
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South Carolina
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Charleston, South Carolina, Forenede Stater
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Columbia, South Carolina, Forenede Stater
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Texas
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Arlington, Texas, Forenede Stater
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Dallas, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater
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Virginia
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Falls Church, Virginia, Forenede Stater
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Norfolk, Virginia, Forenede Stater
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Washington
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Seattle, Washington, Forenede Stater
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Clichy, Frankrig
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Creteil, Frankrig
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Grenoble, Frankrig
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Lille, Frankrig
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Lyon, Frankrig
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Paris, Frankrig
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Pessac, Frankrig
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Vandoeuvre Les Nancy, Frankrig
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Villejuif Cedex, Frankrig
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Dublin, Irland
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Dublin 9, Irland
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Mex Ctity, Mexico
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Mexico, Mexico
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Monterrey, Mexico
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Bialystok, Polen
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Bydgoszcz, Polen
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Czeladz, Polen
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Kielce, Polen
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Krakow, Polen
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Warszawa, Polen
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Barcelona, Spanien
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Barcelona N/A, Spanien
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Madrid, Spanien
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Malaga N/A, Spanien
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Santander N/A, Spanien
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Sevilla N/A, Spanien
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Valencia, Spanien
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Göteborg, Sverige
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Malmö, Sverige
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Stockholm, Sverige
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Berlin, Tyskland
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Bochum, Tyskland
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Essen, Tyskland
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Frankfurt, Tyskland
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Hamburg, Tyskland
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Kiel, Tyskland
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Mainz, Tyskland
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Regensburg, Tyskland
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Graz N/A, Østrig
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Linz, Østrig
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Wien, Østrig
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
- Patients should not have had any previous treatment for hepatitis C
- Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
- Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
- A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Exclusion Criteria:
- Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
- Patient has a pre-existing psychiatric condition
- Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
- Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 001 T(q8h) / PR
Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
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Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
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Eksperimentel: 002 T(b.i.d.) / PR
Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)
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Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
750 mg (2 oral tablets) every 8 hours for 12 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)
Tidsramme: End of trial, 12 weeks after last planned dose
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The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned).
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
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End of trial, 12 weeks after last planned dose
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)
Tidsramme: End of trial, 24 weeks after last planned dose
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The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication.
SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).
The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time.
Consequently, by definition of SVR12, they were counted as not having achieved SVR12.
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End of trial, 24 weeks after last planned dose
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Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)
Tidsramme: End of trial, 72 weeks after the start of study medication
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The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned).
SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).
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End of trial, 72 weeks after the start of study medication
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Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.
Tidsramme: Baseline, Week 4 and Week 4+12.
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The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.
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Baseline, Week 4 and Week 4+12.
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Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs
Tidsramme: Week 4, 12, 24, 32, 40
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The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.
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Week 4, 12, 24, 32, 40
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Percentage of Participants Who Relapsed During Follow-up Period
Tidsramme: During Follow-Up (24 weeks after the last dose of study drug)
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The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
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During Follow-Up (24 weeks after the last dose of study drug)
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Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)
Tidsramme: End of trial, 12 weeks after the last planned dose
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The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.
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End of trial, 12 weeks after the last planned dose
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
- Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Enterovirus infektioner
- Picornaviridae infektioner
- Hepatitis
- Hepatitis A
- Hepatitis C
- Virussygdomme
- Hepatitis, kronisk
- Hepatitis C, kronisk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Antimetabolitter
- Antineoplastiske midler
- Immunologiske faktorer
- Interferoner
- Interferon-alfa
- Ribavirin
- Peginterferon alfa-2a
- Interferon alfa-2
Andre undersøgelses-id-numre
- CR013711
- OPTIMIZE-HCV (Anden identifikator: Janssen Infectious Diseases BVBA)
- VX-950-C211 (Anden identifikator: Janssen Infectious Diseases BVBA)
- 2010-021628-84 (EudraCT nummer)
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AbbVie (prior sponsor, Abbott)AfsluttetKronisk hepatitis C | Hepatitis C genotype 1 | Hepatitis C (HCV)Forenede Stater, Australien, Canada, Frankrig, Tyskland, New Zealand, Puerto Rico, Spanien, Det Forenede Kongerige
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GlobeImmuneAfsluttet
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R-PharmAlmedis; Scientific Center EFiS; ChromSystemsLabAfsluttetKronisk hepatitis c genotype 1Den Russiske Føderation
Kliniske forsøg med Ribavirin
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Hoffmann-La RocheAfsluttet
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Janssen-Cilag International NVIkke længere tilgængeligHepatitis CAustralien, Belgien, Tyskland, Spanien, Schweiz, Rumænien, Serbien, Grækenland, New Zealand, Brasilien, Den Russiske Føderation, Østrig, Ungarn, Tjekkiet, Luxembourg
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Conatus Pharmaceuticals Inc.Afsluttet
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National Institute of Diabetes and Digestive and...AfsluttetHepatitis C, kroniskForenede Stater
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Memorial Sloan Kettering Cancer CenterAfsluttetHOVED-HALS KræftForenede Stater
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Kaohsiung Medical University Chung-Ho Memorial...Afsluttet
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Biolex Therapeutics, Inc.AfsluttetHepatitis C, kroniskBulgarien, Rumænien, Israel
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University of Colorado, DenverJanssen Scientific Affairs, LLCAfsluttet
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University of Roma La SapienzaAfsluttet
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