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
NCT ID: NCT01132313
Last Updated: 2016-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
488 participants
INTERVENTIONAL
2010-05-31
2014-10-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
Ribavirin
48 weeks, according to label
BI 201335
24 weeks, QD
BI 207127
4 weeks, high dose, TID
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
BI 207127
4 weeks, low dose TID
BI 201335
24 weeks, QD
Ribavirin
48 weeks, according to label
3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
BI 207127
16 weeks, high dose, TID
BI 201335
16 weeks, QD
Ribavirin
16 weeks, according to label
4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
BI 207127
28 weeks, high dose, TID
Ribavirin
28 weeks, according to label
BI 201335
28 weeks, QD
5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
BI 201335
40 weeks, QD
BI 207127
40 weeks, high dose, TID
Ribavirin
40 weeks, according to label
6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Ribavirin
28 weeks, according to label
BI 201335
28 weeks, QD
BI 207217
28 weeks, high dose BID
7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
BI 207127
28 weeks, high dose, TID
BI 201335
28 weeks, QD
8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
BI 207127
16 weeks, high dose, BID
Ribavirin
16 weeks, according to label
BI 201335
16 weeks, QD
9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
BI 207127
24 weeks, very high dose, BID
BI 201335
24 weeks, QD
Ribavirin
24 weeks, according to label
10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
BI 201335
24 weeks, QD
BI 207127
24 weeks, high dose, TID
Ribavirin
24 weeks, according to label
11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
Ribavirin
16 weeks, according to label
BI 207127
16 weeks, standard dose, BID
BI 201335
16 weeks, QD
12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
Ribavirin
24 weeks, according to label
BI 201335
24 weeks, QD
BI 207127
24 weeks, standard dose, BID
Interventions
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BI 207127
28 weeks, high dose, TID
BI 201335
40 weeks, QD
BI 207127
4 weeks, low dose TID
BI 201335
24 weeks, QD
Ribavirin
16 weeks, according to label
Ribavirin
28 weeks, according to label
Ribavirin
28 weeks, according to label
BI 207127
40 weeks, high dose, TID
BI 207127
24 weeks, very high dose, BID
BI 207127
16 weeks, standard dose, BID
BI 201335
24 weeks, QD
Ribavirin
48 weeks, according to label
Ribavirin
40 weeks, according to label
BI 207127
16 weeks, high dose, TID
BI 207127
28 weeks, high dose, TID
BI 201335
28 weeks, QD
BI 201335
16 weeks, QD
Ribavirin
24 weeks, according to label
BI 201335
24 weeks, QD
BI 201335
28 weeks, QD
BI 207127
24 weeks, standard dose, BID
BI 201335
24 weeks, QD
BI 201335
16 weeks, QD
BI 207127
16 weeks, high dose, BID
BI 201335
24 weeks, QD
Ribavirin
16 weeks, according to label
Ribavirin
16 weeks, according to label
BI 207217
28 weeks, high dose BID
BI 201335
16 weeks, QD
BI 207127
24 weeks, high dose, TID
Ribavirin
48 weeks, according to label
BI 207127
4 weeks, high dose, TID
BI 201335
28 weeks, QD
Ribavirin
24 weeks, according to label
Ribavirin
24 weeks, according to label
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1241.21.0003 Boehringer Ingelheim Investigational Site
La Jolla, California, United States
1241.21.0006 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1241.21.0004 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1241.21.0011 Boehringer Ingelheim Investigational Site
Palm Harbor, Florida, United States
1241.21.0013 Boehringer Ingelheim Investigational Site
Valparaiso, Indiana, United States
1241.21.0008 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
1241.21.0019 Boehringer Ingelheim Investigational Site
Fayetteville, North Carolina, United States
1241.21.0012 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1241.21.0005 Boehringer Ingelheim Investigational Site
Austin, Texas, United States
1241.21.0007 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1241.21.0010 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1241.21.0017 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
1241.21.61002 Boehringer Ingelheim Investigational Site
Heidelberg, Victoria, Australia
1241.21.61001 Boehringer Ingelheim Investigational Site
Melbourne, Victoria, Australia
1241.21.43003 Boehringer Ingelheim Investigational Site
Linz, , Austria
1241.21.43001 Boehringer Ingelheim Investigational Site
Vienna, , Austria
1241.21.43002 Boehringer Ingelheim Investigational Site
Vienna, , Austria
1241.21.33005 Boehringer Ingelheim Investigational Site
Clichy, , France
1241.21.33007 Boehringer Ingelheim Investigational Site
Grenoble Cédex 9, , France
1241.21.33003 Boehringer Ingelheim Investigational Site
Lyon, , France
1241.21.33001 Boehringer Ingelheim Investigational Site
Marseille, , France
1241.21.33002 Boehringer Ingelheim Investigational Site
Montpellier, , France
1241.21.33004 Boehringer Ingelheim Investigational Site
Paris, , France
1241.21.33008 Boehringer Ingelheim Investigational Site
Paris, , France
1241.21.33006 Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy, , France
1241.21.49002 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1241.21.49003 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1241.21.49007 Boehringer Ingelheim Investigational Site
Düsseldorf, , Germany
1241.21.49005 Boehringer Ingelheim Investigational Site
Esslingen am Neckar, , Germany
1241.21.49001 Boehringer Ingelheim Investigational Site
Frankfurt am Main, , Germany
1241.21.49006 Boehringer Ingelheim Investigational Site
Hamburg, , Germany
1241.21.49009 Boehringer Ingelheim Investigational Site
Hanover, , Germany
1241.21.49004 Boehringer Ingelheim Investigational Site
Leipzig, , Germany
1241.21.49008 Boehringer Ingelheim Investigational Site
Mainz, , Germany
1241.21.64001 Boehringer Ingelheim Investigational Site
Auckland NZ, , New Zealand
1241.21.35103 Boehringer Ingelheim Investigational Site
Aveiro, , Portugal
1241.21.35104 Boehringer Ingelheim Investigational Site
Coimbra, , Portugal
1241.21.35101 Boehringer Ingelheim Investigational Site
Lisbon, , Portugal
1241.21.35105 Boehringer Ingelheim Investigational Site
Lisbon, , Portugal
1241.21.35102 Boehringer Ingelheim Investigational Site
Porto, , Portugal
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
Bucharest, , Romania
1241.21.34002 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
1241.21.34005 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
1241.21.34003 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1241.21.34004 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1241.21.34001 Boehringer Ingelheim Investigational Site
Majadahonda-Madrid, , Spain
1241.21.34006 Boehringer Ingelheim Investigational Site
Valencia, , Spain
1241.21.41003 Boehringer Ingelheim Investigational Site
Basel, , Switzerland
1241.21.41006 Boehringer Ingelheim Investigational Site
Bern, , Switzerland
1241.21.41001 Boehringer Ingelheim Investigational Site
Sankt Gallen, , Switzerland
1241.21.41002 Boehringer Ingelheim Investigational Site
Zurich, , Switzerland
Countries
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References
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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.
Other Identifiers
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2009-018197-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1241.21
Identifier Type: -
Identifier Source: org_study_id
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