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 december 2015 bijgewerkt door: 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)
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 201335
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 201335
- Geneesmiddel: Ribavirin
- Geneesmiddel: Ribavirin
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 207127
- Geneesmiddel: Ribavirin
- Geneesmiddel: Ribavirin
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 201335
- Geneesmiddel: BI 201335
- Geneesmiddel: Ribavirin
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 207127
- Geneesmiddel: BI 207217
Studietype
Ingrijpend
Inschrijving (Werkelijk)
488
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Victoria
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Heidelberg, Victoria, Australië
- 1241.21.61002 Boehringer Ingelheim Investigational Site
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Melbourne, Victoria, Australië
- 1241.21.61001 Boehringer Ingelheim Investigational Site
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Berlin, Duitsland
- 1241.21.49002 Boehringer Ingelheim Investigational Site
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Berlin, Duitsland
- 1241.21.49003 Boehringer Ingelheim Investigational Site
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Düsseldorf, Duitsland
- 1241.21.49007 Boehringer Ingelheim Investigational Site
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Esslingen, Duitsland
- 1241.21.49005 Boehringer Ingelheim Investigational Site
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Frankfurt am Main, Duitsland
- 1241.21.49001 Boehringer Ingelheim Investigational Site
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Hamburg, Duitsland
- 1241.21.49006 Boehringer Ingelheim Investigational Site
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Hannover, Duitsland
- 1241.21.49009 Boehringer Ingelheim Investigational Site
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Leipzig, Duitsland
- 1241.21.49004 Boehringer Ingelheim Investigational Site
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Mainz, Duitsland
- 1241.21.49008 Boehringer Ingelheim Investigational Site
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Clichy, Frankrijk
- 1241.21.33005 Boehringer Ingelheim Investigational Site
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Grenoble cédex 9, Frankrijk
- 1241.21.33007 Boehringer Ingelheim Investigational Site
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Lyon, Frankrijk
- 1241.21.33003 Boehringer Ingelheim Investigational Site
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Marseille, Frankrijk
- 1241.21.33001 Boehringer Ingelheim Investigational Site
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Montpellier, Frankrijk
- 1241.21.33002 Boehringer Ingelheim Investigational Site
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Paris, Frankrijk
- 1241.21.33004 Boehringer Ingelheim Investigational Site
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Paris, Frankrijk
- 1241.21.33008 Boehringer Ingelheim Investigational Site
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Vandoeuvre Cedex, Frankrijk
- 1241.21.33006 Boehringer Ingelheim Investigational Site
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Auckland NZ, Nieuw-Zeeland
- 1241.21.64001 Boehringer Ingelheim Investigational Site
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Linz, Oostenrijk
- 1241.21.43003 Boehringer Ingelheim Investigational Site
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Wien, Oostenrijk
- 1241.21.43001 Boehringer Ingelheim Investigational Site
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Wien, Oostenrijk
- 1241.21.43002 Boehringer Ingelheim Investigational Site
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Aveiro, Portugal
- 1241.21.35103 Boehringer Ingelheim Investigational Site
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Coimbra, Portugal
- 1241.21.35104 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1241.21.35101 Boehringer Ingelheim Investigational Site
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Lisboa, Portugal
- 1241.21.35105 Boehringer Ingelheim Investigational Site
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Porto, Portugal
- 1241.21.35102 Boehringer Ingelheim Investigational Site
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Bucharest, Roemenië
- 1241.21.40001 Boehringer Ingelheim Investigational Site
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Bucharest, Roemenië
- 1241.21.40002 Boehringer Ingelheim Investigational Site
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Bucharest, Roemenië
- 1241.21.40003 Boehringer Ingelheim Investigational Site
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Barcelona, Spanje
- 1241.21.34002 Boehringer Ingelheim Investigational Site
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Barcelona, Spanje
- 1241.21.34005 Boehringer Ingelheim Investigational Site
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Madrid, Spanje
- 1241.21.34003 Boehringer Ingelheim Investigational Site
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Madrid, Spanje
- 1241.21.34004 Boehringer Ingelheim Investigational Site
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Majadahonda-Madrid, Spanje
- 1241.21.34001 Boehringer Ingelheim Investigational Site
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Valencia, Spanje
- 1241.21.34006 Boehringer Ingelheim Investigational Site
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California
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La Jolla, California, Verenigde Staten
- 1241.21.0003 Boehringer Ingelheim Investigational Site
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San Diego, California, Verenigde Staten
- 1241.21.0006 Boehringer Ingelheim Investigational Site
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San Francisco, California, Verenigde Staten
- 1241.21.0004 Boehringer Ingelheim Investigational Site
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Florida
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Palm Harbor, Florida, Verenigde Staten
- 1241.21.0011 Boehringer Ingelheim Investigational Site
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Indiana
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Valparaiso, Indiana, Verenigde Staten
- 1241.21.0013 Boehringer Ingelheim Investigational Site
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Massachusetts
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Springfield, Massachusetts, Verenigde Staten
- 1241.21.0008 Boehringer Ingelheim Investigational Site
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North Carolina
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Fayetteville, North Carolina, Verenigde Staten
- 1241.21.0019 Boehringer Ingelheim Investigational Site
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Texas
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Arlington, Texas, Verenigde Staten
- 1241.21.0012 Boehringer Ingelheim Investigational Site
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Austin, Texas, Verenigde Staten
- 1241.21.0005 Boehringer Ingelheim Investigational Site
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Dallas, Texas, Verenigde Staten
- 1241.21.0007 Boehringer Ingelheim Investigational Site
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Houston, Texas, Verenigde Staten
- 1241.21.0010 Boehringer Ingelheim Investigational Site
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Washington
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Seattle, Washington, Verenigde Staten
- 1241.21.0017 Boehringer Ingelheim Investigational Site
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Basel, Zwitserland
- 1241.21.41003 Boehringer Ingelheim Investigational Site
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Bern, Zwitserland
- 1241.21.41006 Boehringer Ingelheim Investigational Site
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St. Gallen, Zwitserland
- 1241.21.41001 Boehringer Ingelheim Investigational Site
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Zürich, Zwitserland
- 1241.21.41002 Boehringer Ingelheim Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
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|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
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Experimenteel: 5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
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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
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Experimenteel: 6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
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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
|
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Experimenteel: 7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
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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
|
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Experimenteel: 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
|
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Experimenteel: 9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
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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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Part 1: Rapid Virological Response (RVR)
Tijdsspanne: 4 weeks
|
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
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4 weeks
|
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Part 2: Sustained Virological Response (SVR)
Tijdsspanne: 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
|
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Part 3 and 4: Sustained Virological Response (SVR)
Tijdsspanne: From drug administration until 12 weeks after end of treatment, up to 36 weeks
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Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
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From drug administration until 12 weeks after end of treatment, up to 36 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Part 1: Time to Virological Response
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 4 weeks
|
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
|
4 weeks
|
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Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Tijdsspanne: 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
Tijdsspanne: 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
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Week 4 and 12
|
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Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Tijdsspanne: up to 28 weeks
|
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
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up to 28 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2010
Primaire voltooiing (Werkelijk)
1 oktober 2014
Studie voltooiing (Werkelijk)
1 oktober 2014
Studieregistratiedata
Eerst ingediend
3 mei 2010
Eerst ingediend dat voldeed aan de QC-criteria
26 mei 2010
Eerst geplaatst (Schatting)
28 mei 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
1 februari 2016
Laatste update ingediend die voldeed aan QC-criteria
22 december 2015
Laatst geverifieerd
1 december 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Hepatitis, chronisch
- Hepatitis
- Hepatitis C
- Hepatitis C, chronisch
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Antimetabolieten
- Ribavirine
Andere studie-ID-nummers
- 1241.21
- 2009-018197-66 (EudraCT-nummer: EudraCT)
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