Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
22 grudnia 2015 zaktualizowane przez: Boehringer Ingelheim
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.
Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
488
Faza
- Faza 2
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Victoria
-
Heidelberg, Victoria, Australia
- 1241.21.61002 Boehringer Ingelheim Investigational Site
-
Melbourne, Victoria, Australia
- 1241.21.61001 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Linz, Austria
- 1241.21.43003 Boehringer Ingelheim Investigational Site
-
Wien, Austria
- 1241.21.43001 Boehringer Ingelheim Investigational Site
-
Wien, Austria
- 1241.21.43002 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Clichy, Francja
- 1241.21.33005 Boehringer Ingelheim Investigational Site
-
Grenoble cédex 9, Francja
- 1241.21.33007 Boehringer Ingelheim Investigational Site
-
Lyon, Francja
- 1241.21.33003 Boehringer Ingelheim Investigational Site
-
Marseille, Francja
- 1241.21.33001 Boehringer Ingelheim Investigational Site
-
Montpellier, Francja
- 1241.21.33002 Boehringer Ingelheim Investigational Site
-
Paris, Francja
- 1241.21.33004 Boehringer Ingelheim Investigational Site
-
Paris, Francja
- 1241.21.33008 Boehringer Ingelheim Investigational Site
-
Vandoeuvre Cedex, Francja
- 1241.21.33006 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Barcelona, Hiszpania
- 1241.21.34002 Boehringer Ingelheim Investigational Site
-
Barcelona, Hiszpania
- 1241.21.34005 Boehringer Ingelheim Investigational Site
-
Madrid, Hiszpania
- 1241.21.34003 Boehringer Ingelheim Investigational Site
-
Madrid, Hiszpania
- 1241.21.34004 Boehringer Ingelheim Investigational Site
-
Majadahonda-Madrid, Hiszpania
- 1241.21.34001 Boehringer Ingelheim Investigational Site
-
Valencia, Hiszpania
- 1241.21.34006 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Berlin, Niemcy
- 1241.21.49002 Boehringer Ingelheim Investigational Site
-
Berlin, Niemcy
- 1241.21.49003 Boehringer Ingelheim Investigational Site
-
Düsseldorf, Niemcy
- 1241.21.49007 Boehringer Ingelheim Investigational Site
-
Esslingen, Niemcy
- 1241.21.49005 Boehringer Ingelheim Investigational Site
-
Frankfurt am Main, Niemcy
- 1241.21.49001 Boehringer Ingelheim Investigational Site
-
Hamburg, Niemcy
- 1241.21.49006 Boehringer Ingelheim Investigational Site
-
Hannover, Niemcy
- 1241.21.49009 Boehringer Ingelheim Investigational Site
-
Leipzig, Niemcy
- 1241.21.49004 Boehringer Ingelheim Investigational Site
-
Mainz, Niemcy
- 1241.21.49008 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Auckland NZ, Nowa Zelandia
- 1241.21.64001 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Aveiro, Portugalia
- 1241.21.35103 Boehringer Ingelheim Investigational Site
-
Coimbra, Portugalia
- 1241.21.35104 Boehringer Ingelheim Investigational Site
-
Lisboa, Portugalia
- 1241.21.35101 Boehringer Ingelheim Investigational Site
-
Lisboa, Portugalia
- 1241.21.35105 Boehringer Ingelheim Investigational Site
-
Porto, Portugalia
- 1241.21.35102 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bucharest, Rumunia
- 1241.21.40001 Boehringer Ingelheim Investigational Site
-
Bucharest, Rumunia
- 1241.21.40002 Boehringer Ingelheim Investigational Site
-
Bucharest, Rumunia
- 1241.21.40003 Boehringer Ingelheim Investigational Site
-
-
-
-
California
-
La Jolla, California, Stany Zjednoczone
- 1241.21.0003 Boehringer Ingelheim Investigational Site
-
San Diego, California, Stany Zjednoczone
- 1241.21.0006 Boehringer Ingelheim Investigational Site
-
San Francisco, California, Stany Zjednoczone
- 1241.21.0004 Boehringer Ingelheim Investigational Site
-
-
Florida
-
Palm Harbor, Florida, Stany Zjednoczone
- 1241.21.0011 Boehringer Ingelheim Investigational Site
-
-
Indiana
-
Valparaiso, Indiana, Stany Zjednoczone
- 1241.21.0013 Boehringer Ingelheim Investigational Site
-
-
Massachusetts
-
Springfield, Massachusetts, Stany Zjednoczone
- 1241.21.0008 Boehringer Ingelheim Investigational Site
-
-
North Carolina
-
Fayetteville, North Carolina, Stany Zjednoczone
- 1241.21.0019 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Arlington, Texas, Stany Zjednoczone
- 1241.21.0012 Boehringer Ingelheim Investigational Site
-
Austin, Texas, Stany Zjednoczone
- 1241.21.0005 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Stany Zjednoczone
- 1241.21.0007 Boehringer Ingelheim Investigational Site
-
Houston, Texas, Stany Zjednoczone
- 1241.21.0010 Boehringer Ingelheim Investigational Site
-
-
Washington
-
Seattle, Washington, Stany Zjednoczone
- 1241.21.0017 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Basel, Szwajcaria
- 1241.21.41003 Boehringer Ingelheim Investigational Site
-
Bern, Szwajcaria
- 1241.21.41006 Boehringer Ingelheim Investigational Site
-
St. Gallen, Szwajcaria
- 1241.21.41001 Boehringer Ingelheim Investigational Site
-
Zürich, Szwajcaria
- 1241.21.41002 Boehringer Ingelheim Investigational Site
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 75 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion criteria:
- Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
- Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
- Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
- HCV RNA >=10,000 IU/mL at screening
- Liver biopsy within two years or fibroscan within six months prior to baseline
- Liver biopsy within two years or fibroscan within 6 months prior to screening
- Age 18-75 years
Exclusion criteria:
- Hepatitis C virus (HCV) infection of mixed genotype
- Evidence of liver disease due to causes other than chronic HCV infection
- Positive ELISA for human immunodeficiency virus (HIV)
- Hepatitis B virus (HBV) infection
- Decompensated liver disease or history of decompensated liver disease
- Active or suspected malignancy within the last 5 years
- Ongoing or historical photosensitivity or recurrent rash
- History of alcohol or drug abuse (except cannabis) within the past 12 months
- Body mass index (BMI)I <18 or > 35 kg/m2
- Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
- Known hypersensitivity to any ingredient of the study drugs
- A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
- Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
- Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
- AST or ALT >5xULN
- INR prolonged to >1.7xULN
- Requirement for chronic systemic corticosteroids
- Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
- Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
- Contraindications pertaining to PegIFN or RBV
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 1
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
|
40 weeks, QD
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
48 weeks, according to label
40 weeks, according to label
28 weeks, QD
16 weeks, QD
24 weeks, according to label
28 weeks, high dose BID
|
|
Eksperymentalny: 7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
|
Eksperymentalny: 12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
|
28 weeks, high dose, TID
40 weeks, QD
4 weeks, low dose TID
24 weeks, QD
16 weeks, according to label
28 weeks, according to label
40 weeks, high dose, TID
24 weeks, very high dose, BID
16 weeks, standard dose, BID
48 weeks, according to label
40 weeks, according to label
16 weeks, high dose, TID
28 weeks, QD
16 weeks, QD
24 weeks, according to label
24 weeks, standard dose, BID
16 weeks, high dose, BID
24 weeks, high dose, TID
4 weeks, high dose, TID
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 1: Rapid Virological Response (RVR)
Ramy czasowe: 4 weeks
|
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
|
4 weeks
|
|
Part 2: Sustained Virological Response (SVR)
Ramy czasowe: From drug administration until 12 weeks after end of treatment, up to 52 weeks
|
Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
|
From drug administration until 12 weeks after end of treatment, up to 52 weeks
|
|
Part 3 and 4: Sustained Virological Response (SVR)
Ramy czasowe: From drug administration until 12 weeks after end of treatment, up to 36 weeks
|
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
|
From drug administration until 12 weeks after end of treatment, up to 36 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 1: Time to Virological Response
Ramy czasowe: From drug administration until end of drug administration, up to 4 weeks
|
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL.
The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
|
From drug administration until end of drug administration, up to 4 weeks
|
|
Part 2: Time to Virological Response
Ramy czasowe: From drug administration until end of drug administration, up to 40 weeks
|
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL.
The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
|
From drug administration until end of drug administration, up to 40 weeks
|
|
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Ramy czasowe: 4 weeks
|
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
|
4 weeks
|
|
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Ramy czasowe: 4 weeks and 24 weeks after the end of treatment, up to 64 weeks
|
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
|
4 weeks and 24 weeks after the end of treatment, up to 64 weeks
|
|
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Ramy czasowe: Week 4 and 12
|
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
|
Week 4 and 12
|
|
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Ramy czasowe: up to 28 weeks
|
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
|
up to 28 weeks
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Bocher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.
- Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Bocher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.
- Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.
- Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Bocher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.
- Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Bocher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 maja 2010
Zakończenie podstawowe (Rzeczywisty)
1 października 2014
Ukończenie studiów (Rzeczywisty)
1 października 2014
Daty rejestracji na studia
Pierwszy przesłany
3 maja 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 maja 2010
Pierwszy wysłany (Oszacować)
28 maja 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
1 lutego 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 grudnia 2015
Ostatnia weryfikacja
1 grudnia 2015
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby Układu Pokarmowego
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje przenoszone przez krew
- Choroby zakaźne
- Choroby wątroby
- Infekcje Flaviviridae
- Zapalenie wątroby, wirusowe, ludzkie
- Zapalenie wątroby, przewlekłe
- Zapalenie wątroby
- Wirusowe zapalenie wątroby typu C
- Wirusowe zapalenie wątroby typu C, przewlekłe
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwinfekcyjne
- Środki przeciwwirusowe
- Antymetabolity
- Rybawiryna
Inne numery identyfikacyjne badania
- 1241.21
- 2009-018197-66 (Numer EudraCT: EudraCT)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Wirusowe zapalenie wątroby typu C, przewlekłe
-
Dokuz Eylul UniversityEge UniversityZakończonyMMP9 | TIMP1 | MMP9-1562 C/T | TIMP1 372 T/CIndyk
-
Meir Medical CenterZakończonyOpracowanie nowatorskiej techniki pomiaru współczynnika C/D z cyfrowych obrazów dysków optycznych stereo | Odtwarzalność pomiarów C/D wewnątrz obserwatora | Zmienność pomiarów C/D między obserwatorami
-
Johann Wolfgang Goethe University HospitalZakończony
-
University College CorkDupont Applied BiosciencesRekrutacyjny
-
University Hospital, GrenobleClinical Investigation Centre for Innovative Technology NetworkZakończony
-
AronPharma Sp. z o. o.Medical University of Warsaw; Medical University of GdanskZakończonyBiodostępność witaminy CPolska
-
University Hospital, CaenZakończonyHemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)C. Zabieg chirurgiczny; SercowyFrancja
-
University of Sao Paulo General HospitalInCor Heart Institute; Chinese Academy of Medical Sciences, Fuwai Hospital; Beneficência... i inni współpracownicyNieznanyC. Zabieg chirurgiczny; SercowyBrazylia
-
Hongwen JiZakończony
-
Seoul National University HospitalSMG-SNU Boramae Medical CenterZakończonyC. Zabieg chirurgiczny; SercowyRepublika Korei
Badania kliniczne na BI 207127
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończonyWirusowe zapalenie wątroby typu C, przewlekłeFrancja, Niemcy, Szwajcaria
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończony
-
Boehringer IngelheimZakończonyWirusowe zapalenie wątroby typu C, przewlekłeStany Zjednoczone, Niemcy, Hiszpania, Zjednoczone Królestwo