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. desember 2015 oppdatert av: 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)
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
- Legemiddel: BI 207127
- Legemiddel: BI 201335
- Legemiddel: BI 207127
- Legemiddel: BI 201335
- Legemiddel: Ribavirin
- Legemiddel: Ribavirin
- Legemiddel: BI 207127
- Legemiddel: BI 207127
- Legemiddel: BI 207127
- Legemiddel: Ribavirin
- Legemiddel: Ribavirin
- Legemiddel: BI 207127
- Legemiddel: BI 201335
- Legemiddel: BI 201335
- Legemiddel: Ribavirin
- Legemiddel: BI 207127
- Legemiddel: BI 207127
- Legemiddel: BI 207127
- Legemiddel: BI 207127
- Legemiddel: BI 207217
Studietype
Intervensjonell
Registrering (Faktiske)
488
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Victoria
-
Heidelberg, Victoria, Australia
- 1241.21.61002 Boehringer Ingelheim Investigational Site
-
Melbourne, Victoria, Australia
- 1241.21.61001 Boehringer Ingelheim Investigational Site
-
-
-
-
California
-
La Jolla, California, Forente stater
- 1241.21.0003 Boehringer Ingelheim Investigational Site
-
San Diego, California, Forente stater
- 1241.21.0006 Boehringer Ingelheim Investigational Site
-
San Francisco, California, Forente stater
- 1241.21.0004 Boehringer Ingelheim Investigational Site
-
-
Florida
-
Palm Harbor, Florida, Forente stater
- 1241.21.0011 Boehringer Ingelheim Investigational Site
-
-
Indiana
-
Valparaiso, Indiana, Forente stater
- 1241.21.0013 Boehringer Ingelheim Investigational Site
-
-
Massachusetts
-
Springfield, Massachusetts, Forente stater
- 1241.21.0008 Boehringer Ingelheim Investigational Site
-
-
North Carolina
-
Fayetteville, North Carolina, Forente stater
- 1241.21.0019 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Arlington, Texas, Forente stater
- 1241.21.0012 Boehringer Ingelheim Investigational Site
-
Austin, Texas, Forente stater
- 1241.21.0005 Boehringer Ingelheim Investigational Site
-
Dallas, Texas, Forente stater
- 1241.21.0007 Boehringer Ingelheim Investigational Site
-
Houston, Texas, Forente stater
- 1241.21.0010 Boehringer Ingelheim Investigational Site
-
-
Washington
-
Seattle, Washington, Forente stater
- 1241.21.0017 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Clichy, Frankrike
- 1241.21.33005 Boehringer Ingelheim Investigational Site
-
Grenoble cédex 9, Frankrike
- 1241.21.33007 Boehringer Ingelheim Investigational Site
-
Lyon, Frankrike
- 1241.21.33003 Boehringer Ingelheim Investigational Site
-
Marseille, Frankrike
- 1241.21.33001 Boehringer Ingelheim Investigational Site
-
Montpellier, Frankrike
- 1241.21.33002 Boehringer Ingelheim Investigational Site
-
Paris, Frankrike
- 1241.21.33004 Boehringer Ingelheim Investigational Site
-
Paris, Frankrike
- 1241.21.33008 Boehringer Ingelheim Investigational Site
-
Vandoeuvre Cedex, Frankrike
- 1241.21.33006 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Auckland NZ, New Zealand
- 1241.21.64001 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Aveiro, Portugal
- 1241.21.35103 Boehringer Ingelheim Investigational Site
-
Coimbra, Portugal
- 1241.21.35104 Boehringer Ingelheim Investigational Site
-
Lisboa, Portugal
- 1241.21.35101 Boehringer Ingelheim Investigational Site
-
Lisboa, Portugal
- 1241.21.35105 Boehringer Ingelheim Investigational Site
-
Porto, Portugal
- 1241.21.35102 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bucharest, Romania
- 1241.21.40001 Boehringer Ingelheim Investigational Site
-
Bucharest, Romania
- 1241.21.40002 Boehringer Ingelheim Investigational Site
-
Bucharest, Romania
- 1241.21.40003 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Barcelona, Spania
- 1241.21.34002 Boehringer Ingelheim Investigational Site
-
Barcelona, Spania
- 1241.21.34005 Boehringer Ingelheim Investigational Site
-
Madrid, Spania
- 1241.21.34003 Boehringer Ingelheim Investigational Site
-
Madrid, Spania
- 1241.21.34004 Boehringer Ingelheim Investigational Site
-
Majadahonda-Madrid, Spania
- 1241.21.34001 Boehringer Ingelheim Investigational Site
-
Valencia, Spania
- 1241.21.34006 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Basel, Sveits
- 1241.21.41003 Boehringer Ingelheim Investigational Site
-
Bern, Sveits
- 1241.21.41006 Boehringer Ingelheim Investigational Site
-
St. Gallen, Sveits
- 1241.21.41001 Boehringer Ingelheim Investigational Site
-
Zürich, Sveits
- 1241.21.41002 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Berlin, Tyskland
- 1241.21.49002 Boehringer Ingelheim Investigational Site
-
Berlin, Tyskland
- 1241.21.49003 Boehringer Ingelheim Investigational Site
-
Düsseldorf, Tyskland
- 1241.21.49007 Boehringer Ingelheim Investigational Site
-
Esslingen, Tyskland
- 1241.21.49005 Boehringer Ingelheim Investigational Site
-
Frankfurt am Main, Tyskland
- 1241.21.49001 Boehringer Ingelheim Investigational Site
-
Hamburg, Tyskland
- 1241.21.49006 Boehringer Ingelheim Investigational Site
-
Hannover, Tyskland
- 1241.21.49009 Boehringer Ingelheim Investigational Site
-
Leipzig, Tyskland
- 1241.21.49004 Boehringer Ingelheim Investigational Site
-
Mainz, Tyskland
- 1241.21.49008 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Linz, Østerrike
- 1241.21.43003 Boehringer Ingelheim Investigational Site
-
Wien, Østerrike
- 1241.21.43001 Boehringer Ingelheim Investigational Site
-
Wien, Østerrike
- 1241.21.43002 Boehringer Ingelheim Investigational Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Rapid Virological Response (RVR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1: Time to Virological Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: up to 28 weeks
|
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
|
up to 28 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2010
Primær fullføring (Faktiske)
1. oktober 2014
Studiet fullført (Faktiske)
1. oktober 2014
Datoer for studieregistrering
Først innsendt
3. mai 2010
Først innsendt som oppfylte QC-kriteriene
26. mai 2010
Først lagt ut (Anslag)
28. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. februar 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Hepatitt, kronisk
- Hepatitt
- Hepatitt C
- Hepatitt C, kronisk
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter
- Ribavirin
Andre studie-ID-numre
- 1241.21
- 2009-018197-66 (EudraCT-nummer: EudraCT)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .