A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
9 juli 2014 uppdaterad av: Vertex Pharmaceuticals Incorporated
A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
465
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna
- Birmingham Gastroenterology Associates
-
-
California
-
Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
-
Los Angeles, California, Förenta staterna
- USC
-
San Diego, California, Förenta staterna
- University of California, San Diego
-
San Diego, California, Förenta staterna
- Kaiser Permanente Hepatology Research
-
San Francisco, California, Förenta staterna
- University of California San Francisco
-
-
Colorado
-
Denver, Colorado, Förenta staterna
- University of Colorado Health Sciences Center
-
Englewood, Colorado, Förenta staterna
-
-
Florida
-
Bardenton, Florida, Förenta staterna
-
Gainesville, Florida, Förenta staterna
- University of Florida
-
Jacksonville, Florida, Förenta staterna
- Borland-Groover Clinic
-
Jacksonville, Florida, Förenta staterna
- Mayo Clinic Jacksonville
-
Miami, Florida, Förenta staterna
-
Sarasota, Florida, Förenta staterna
- University Hepatitis Center at Bach & Godofsky
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna
-
-
Illinois
-
Chicago, Illinois, Förenta staterna
-
-
Indiana
-
Indianapolis, Indiana, Förenta staterna
-
-
Louisiana
-
Baton Rouge, Louisiana, Förenta staterna
- Gulf Coast Research, LLC
-
-
Maine
-
Portland, Maine, Förenta staterna
- Virology Treatment Center, Maine Medical Center
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna
- Beth Isreal Deaconess Medical Center
-
-
Michigan
-
Detroit, Michigan, Förenta staterna
- Henry Ford Hospital
-
-
Missouri
-
St Louis, Missouri, Förenta staterna
- Saint Louis University
-
-
Nebraska
-
Omaha, Nebraska, Förenta staterna
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna
-
-
New York
-
Manhasset, New York, Förenta staterna
- North Shore University Hospital
-
New York, New York, Förenta staterna
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna
- University Internal Medicine Associates, Inc.
-
Cleveland, Ohio, Förenta staterna
- Cleveland Clinic
-
-
Pennsylvania
-
Hershey, Pennsylvania, Förenta staterna
-
Pittsburgh, Pennsylvania, Förenta staterna
-
-
South Carolina
-
Columbia, South Carolina, Förenta staterna
- Columbia Gastroenterology Associates, PA
-
-
Tennessee
-
Germantown, Tennessee, Förenta staterna
- Memphis Gastroenterology Group
-
-
Texas
-
Dallas, Texas, Förenta staterna
- Liver Institute at Methodist Dallas
-
Houston, Texas, Förenta staterna
- Advanced Liver Therapies
-
San Antonio, Texas, Förenta staterna
- Alamo Medical Research
-
-
Virginia
-
Annandale, Virginia, Förenta staterna
-
Fairfax, Virginia, Förenta staterna
- Metropolitan Research
-
Richmond, Virginia, Förenta staterna
-
-
Washington
-
Seattle, Washington, Förenta staterna
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 4N1
- University of Calgary Medical Clinic - Health Science Centre
-
Edmonton, Alberta, Kanada
-
-
British Columbia
-
Vancouver, British Columbia, Kanada
- BC Hepatitis Program
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada
-
-
Ontario
-
Toronto, Ontario, Kanada
-
Toronto, Ontario, Kanada
- Toronto Western Hospital
-
-
-
-
-
Amsterdam, Nederländerna
- Academic Medical Center
-
Leiden, Nederländerna
- Leiden University Medical Center
-
Rotterdam, Nederländerna
- Erasmus MC University Medical Center
-
-
-
-
-
Santurce, Puerto Rico
-
-
-
-
-
Berlin, Tyskland
- Universitätsmedizin Berlin
-
Frankfurt, Tyskland
- University Clinic Frankfurt, Department of Internal Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Males and females between 18 and 70 years old
- Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
- Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
- Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
- Must be judged to be in general good health and able to receive Pegasys® and Copegus®
- No drug or alcohol abuse in the last year
- Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
- If you are a woman, you cannot be in this study if you are pregnant or nursing
Exclusion Criteria:
- Participation in any clinical trial of a HCV protease inhibitor of any duration
- Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
- Diagnosed or suspected hepatocellular carcinoma
- History of or current evidence of decompensated liver disease
- Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
|
läsplatta
Andra namn:
Injektionsvätska, lösning
Andra namn:
läsplatta
Andra namn:
|
|
Experimentell: Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
|
läsplatta
Andra namn:
Injektionsvätska, lösning
Andra namn:
läsplatta
Andra namn:
|
|
Experimentell: Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
|
Injektionsvätska, lösning
Andra namn:
läsplatta
Andra namn:
|
|
Placebo-jämförare: PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
|
läsplatta
Andra namn:
Injektionsvätska, lösning
Andra namn:
Tablet
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Procentandel av försökspersoner med odetekterbart plasmahepatit C-virus (HCV) ribonukleinsyra (RNA) vid vecka 24 efter avslutad studieläkemedelsdosering
Tidsram: 24 veckor efter avslutad studieläkemedelsdosering (upp till vecka 72)
|
Plasma HCV RNA-nivån mättes med användning av Roche TaqMan HCV RNA-analys.
Den nedre detektionsgränsen var 10 internationella enheter per milliliter (IE/ml).
|
24 veckor efter avslutad studieläkemedelsdosering (upp till vecka 72)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
Tidsram: Completion of study drug dosing (up to Week 48)
|
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
|
Completion of study drug dosing (up to Week 48)
|
|
Percentage of Subjects With Undetectable Plasma HCV RNA
Tidsram: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
|
Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
|
Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Baseline up to 2 weeks after last dose of study drug (up to Week 50)
|
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not.
An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug.
SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
"Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
|
Baseline up to 2 weeks after last dose of study drug (up to Week 50)
|
|
Number of Subjects With Viral Relapse
Tidsram: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
|
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay.
The lower limit of detection was 10 international units per milliliter (IU/mL).
|
After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
|
|
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Tidsram: Week 2, 4, 8, 12, 16, 24
|
Only subjects who received telaprevir were to be analyzed for this outcome.
Maximum, minimum and average plasma concentrations observed during assessment period were reported.
|
Week 2, 4, 8, 12, 16, 24
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. doi: 10.1161/CIRCULATIONAHA.110.012237. Epub 2011 Jun 20.
- McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014. Erratum In: N Engl J Med. 2010 Apr 29;362(17):1647. Dosage error in article text.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2007
Primärt slutförande (Faktisk)
1 december 2008
Avslutad studie (Faktisk)
1 april 2009
Studieregistreringsdatum
Först inskickad
8 januari 2007
Först inskickad som uppfyllde QC-kriterierna
8 januari 2007
Första postat (Uppskatta)
11 januari 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 augusti 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juli 2014
Senast verifierad
1 juli 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Hepatit
- Hepatit A
- Hepatit C
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Antimetaboliter
- Antineoplastiska medel
- Immunologiska faktorer
- Interferoner
- Interferon-alfa
- Ribavirin
- Peginterferon alfa-2a
- Interferon alfa-2
Andra studie-ID-nummer
- VX06-950-106
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .